Etentamig

ASH Annual Meeting and Exposition leaves the oncology community buzzing over a series of late-breaking presentations that experts are calling 'unprecedented.' Major pharmaceutical developers such as Johnson & Johnson, Arcellx, Gilead, Bristol Myers Squibb, Regeneron, AbbVie, CellCentric, Adaptive Biotechnologies, and others, presented pivotal data across the multiple myeloma treatment landscape, with results suggesting that long-term disease-free survival—and potentially a 'functional cure'—is becoming a reality for more patients. LAS VEGAS, Dec. 11, 2025 /PRNewswire/ -- The 67th American Society of Hematology (ASH) Annual Meeting, held December 6-9, 2025, in Orlando, Florida, showcased groundbreaking clinical advances in multiple myeloma treatment from leading biopharmaceutical companies. The conference featured unprecedented efficacy data demonstrating potential functional cures and innovative approaches across novel immunotherapies, bispecific antibodies, and next-generation targeted agents, signaling a major shift in how the disease is managed. Download the updated multiple myeloma market report featuring key results from ASH 2025 @ Multiple Myeloma Market Let's dive deep into the promising results presented at the ASH conference 2025 Johnson & Johnson's TECVAYLI Plus DARZALEX: Setting New Standard of Care Johnson & Johnson unveiled late-breaking results from the Phase III MajesTEC-3 study, presenting what has been characterized as the most impressive progression-free survival (PFS) benefit ever demonstrated in a Phase III multiple myeloma trial. The study evaluated the combination of TECVAYLI (teclistamab-cqyv), a first-in-class BCMAxCD3 bispecific antibody, combined with DARZALEX FASPRO (daratumumab plus hyaluronidase-fihj), a subcutaneous anti-CD38 monoclonal antibody. The combination demonstrated a hazard ratio of 0.17 for PFS—described as "the best hazard ratio we've seen in a phase III clinical trial in multiple myeloma" by lead investigator María-Victoria Mateos, MD, PhD, from the University of Salamanca. At three years of follow-up, 83.4% of patients treated with the teclistamab-dara combination remained alive and progression-free compared to just 29.7% in the control arm, with a median PFS not yet reached in the treatment group versus 18.1 months in controls. Beyond PFS, the data demonstrated sustained benefits across secondary endpoints. Complete response rates of 81.8% were achieved with the combination, compared to 31% in the control group, while minimal residual disease (MRD)-negative rates reached 57.6%, compared to 3.4% in controls. Overall survival was significantly prolonged, with a hazard ratio of 0.45; 91% of patients who were progression-free at six months remained progression-free at three years, suggesting a potential "functional cure" for relapsed/refractory multiple myeloma patients. Safety remained manageable despite the combination's potency. Cytokine release syndrome occurred in approximately 60% of patients. Still, it was limited to Grade 1 or 2 severity in all cases, while immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in only 1.1% of patients, all of which resolved. Deaths were approximately 50% lower with the combination compared to controls (15.9% versus 33.1%), with minimal treatment discontinuations due to adverse events (4.6% versus 5.5%). Gilead/Legend Biotech's CARVYKTI: Extended Follow-Up Affirms CAR-T Durability Gilead and Legend Biotech presented extended durability data for CARVYKTI (ciltacabtagene autoleucel), a BCMA-directed CAR T-cell therapy, demonstrating sustained disease control in patients with multiple myeloma. New Phase 3 data revealed that 80.5% of patients had not experienced disease progression at 30 months of follow-up, with 87.3% remaining alive after 2.5 years. The enduring response rates substantially exceed historical outcomes in heavily pretreated patient populations. In earlier trials evaluating cilta-cel after three or more prior lines of therapy, progression-free survival reached 59.9% with an overall survival of 70.6%, underscoring the durability advantage of this single-infusion therapy. The approval of CARVYKTI as a first relapse option represents a significant advancement, allowing earlier intervention in the disease course for appropriate patients. Bristol Myers Squibb's Iberdomide: Deepening Response Depth in Newly Diagnosed Myeloma Bristol Myers Squibb revealed compelling data on iberdomide, an oral cereblon E3 ligase modulator (CELMoD) agent, demonstrating that the drug delivers deep and sustained responses in newly diagnosed multiple myeloma. A Phase 2 clinical trial examining different doses of iberdomide as maintenance therapy following autologous stem-cell transplantation enrolled 120 patients and showed that approximately half achieved MRD negativity (no detectable cancer), with over 80% remaining cancer-free after two years. Additional Phase 1b/2a data supported the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone for transplant-deferred or ineligible newly diagnosed patients, demonstrating robust responses with sustained minimal residual disease (MRD) negativity. A cooperative group analysis of iberdomide maintenance after autologous stem-cell transplantation continued to show benefit, positioning this agent as a valuable maintenance option across multiple treatment settings. Furthermore, BMS presented Phase 1b data on elranatamab combined with iberdomide ( MagnetisMM-30 trial) in relapsed/refractory multiple myeloma patients, achieving a 95.5% objective response rate with a safety profile consistent with known toxicities of each agent. Regeneron's LYNOZYFIC: First BCMA×CD3 Bispecific in Frontline Setting Regeneron showcased data on LYNOZYFIC (linvoseltamab-gcpt), a bispecific antibody targeting BCMA and CD3, highlighting promising early clinical results as a monotherapy for newly diagnosed multiple myeloma patients. The Phase 1/2 LINKER MM4 trial represents the first evaluation of a BCMA×CD3 bispecific antibody as monotherapy in the frontline myeloma setting, potentially redefining initial treatment strategies. Updated results from the LINKER MM2 study, in which LYNOZYFIC was combined with different anti-CD38 monoclonal antibodies in relapsed or refractory patients, further demonstrated the drug's potential to redefine treatment approaches at early disease stages and improve patient outcomes. Regeneron's hematology program demonstrated significant momentum with regulatory approvals for blood cancer treatments throughout 2025. AbbVie's Etentamig: Next-Generation T-Cell Engager Shows Promise AbbVie presented Phase 1b data evaluating etentamig, a BCMAxCD3 bispecific T-cell engager, in combination with pomalidomide and dexamethasone in 85 heavily pretreated relapsed/refractory multiple myeloma patients who had received at least three prior lines of therapy. The combination demonstrated the therapeutic potential of AbbVie's T-cell engager approach in this difficult-to-treat patient population. CellCentric's Inobrodib: Novel Oral Mechanism for Treatment-Resistant Patients CellCentric unveiled Phase 2 dose optimization results for inobrodib in combination with pomalidomide plus dexamethasone, demonstrating strong clinical efficacy in heavily pretreated relapsed/refractory multiple myeloma patients. Among heavily pretreated patients (median five prior lines of therapy) who were pomalidomide-refractory and had previously failed on BCMA and/or T-cell engager therapy, inobrodib achieved objective response rates of 60% at 20 mg and 75% at 30 mg—representing at least a two-fold increase compared to real-world response rates of 25-30% in similar patient populations after BCMA/bispecific agents. As an oral small-molecule drug targeting p300/CBP bromodomains, inobrodib offers a differentiated mechanism of action for patients ineligible for, or after, bispecific and BCMA-targeting agents. The favorable tolerability profile, with the most common adverse events being cytopenias and fatigue, positions this agent as a compelling option for community-based treatment, where more than 70% of myeloma patients are managed. Arcellx's Anitocabtagene Autoleucel: Novel CAR-T Architecture Arcellx presented new clinical data from the iMMagine-1 study evaluating anitocabtagene autoleucel (anito-cel), the first BCMA CAR T-cell therapy utilizing the company's novel compact D-Domain technology, in patients with relapsed or refractory multiple myeloma. This differentiated CAR-T architecture represents an innovative approach to autologous T-cell immunotherapy in multiple myeloma. Adaptive Biotechnologies' clonoSEQ: MRD Testing Drives Treatment Decisions Adaptive Biotechnologies showcased the expanding clinical utility of clonoSEQ, a minimal residual disease (MRD) detection test, with 32 abstracts focused on multiple myeloma at ASH 2025. Presentations highlighted the growing use of clonoSEQ to evaluate treatment response, real-world evidence linking MRD status to clinical outcomes, and guidance on treatment strategies. Notably, Phase 2 AURA trial data involving 200 newly diagnosed multiple myeloma patients demonstrated that profound MRD responses and sustained MRD negativity were associated with significantly enhanced progression-free survival. The test's critical role in identifying optimal candidates for intensified maintenance therapy in MRD-positive patients post-transplant was particularly emphasized, with data showing substantially higher MRD-negativity rates when guided by clonoSEQ. Live MMR Vaccine Safety in Daratumumab-Treated Myeloma Patients New research presented at ASH 2025 addressed an important question regarding vaccine safety in multiple myeloma patients receiving immunosuppressive therapy. A clinical trial of 41 patients with multiple myeloma who had undergone autologous stem-cell transplantation and were receiving daratumumab demonstrated that the live MMR vaccine was safe and well-tolerated in this population. None of the vaccinated patients developed active measles, mumps, or rubella disease following vaccination, with no hospitalizations or deaths reported. Multiple Myeloma Market Implications and Expansion The convergence of unprecedented efficacy data across multiple modalities has profound implications for the multiple myeloma market. The multiple myeloma therapeutic market, estimated at $22 billion in 2024, is projected to grow at a significant CAGR, reaching $33 billion by 2034, growth substantially accelerated by these clinical advances. The rapid advancement of bispecific antibodies, CAR-T therapies, and next-generation proteasome inhibitors has expanded treatment options but intensified competitive pressures. For Johnson & Johnson, overlap between TECVAYLI-based combination regimens and its approved CAR-T product, CARVYKTI, raises a risk of internal market cannibalization, potentially driving the company to accelerate the rollout of combination strategies to protect its commercial footing. Meanwhile, Bristol Myers Squibb, the Genmab/Pfizer alliance, and newer entrants are shaping a market trajectory in which bispecific and CAR-T platforms increasingly dominate the relapsed/refractory landscape. Still, proteasome inhibitors continue to command a significant share in frontline and maintenance settings. In summary, the 2025 ASH Annual Meeting marks a pivotal moment for multiple myeloma treatment. Data showing that bispecific combinations, CAR-T therapies, and other emerging modalities can deliver deep, durable responses, with the possibility of functional cures for some patients, redefines expectations for a disease long viewed as incurable. The combination of unprecedented efficacy, better safety, and improved accessibility driven by manufacturing advances positions the multiple myeloma market for significant growth. Source: Multiple Myeloma Market Report Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. 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Data being presented showcases AbbVie's breadth and depth of research across a range of therapeutic modalities such as T-Cell Engagers, BCL-2 Inhibitors and Antibody-Drug Conjugates for a spectrum of difficult-to-treat blood cancers NORTH CHICAGO, Ill., Dec. 2, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in research across multiple blood cancers including — multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Data across AbbVie's blood cancer portfolio will be featured in multiple oral and poster presentations including investigational compounds etentamig (ABBV-383) and PVEK (pivekimab sunirine), as well as approved therapies EPKINLY® (epcoritamab-bysp) and VENCLEXTA® (venetoclax). "These ASH presentations reinforce AbbVie's leadership in advancing the potential next wave of blood cancer innovation, with clinical data that highlight our commitment to raising the standard of care," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "The data also highlights the depth and diversity of our pipeline and portfolio of approved medicines spanning across T-cell engagers, BCL-2 Inhibitors and ADCs, all designed to address the heterogeneity of blood cancers for a range of patients." Key data from epcoritamab, venetoclax-based treatments, etentamig and PVEK to be highlighted as oral presentations demonstrate promising efficacy, durable responses, and safety profiles across multiple hematologic malignancies and lines of therapy: Fixed-Duration epcoritamab (CD20×CD3 Bispecific T-Cell Engager) in combination with rituximab and lenalidomide (R2) in Relapsed or Refractory FL Results from the randomized phase 3 trial EPCORE FL-1 (NCT05409066) of fixed-duration epcoritamab, in combination with R2 for patients with relapsed or refractory (R/R) FL (n=243) demonstrate significantly superior progression-free survival (PFS) and overall response rates (ORR) compared to standard of care R2 (n=245).1 The study showed that treatment with epcoritamab + R2 (E+R2) reduced the risk of disease progression or death by 79% compared to standard of care R2, with significantly longer PFS in patients treated with E+R2 vs. those treated with R2 (hazard ratio [HR] 0.21; 95% CI: 0.13, 0.33; P<.0001). A preplanned interim analysis was conducted after the first 232 patients achieved 12 months of follow-up post-randomization, and the ORR was significantly improved in patients treated with E+R2 (95.7% [95% CI: 90.2, 98.6]) vs R2 (81.0% [95% CI: 72.7, 87.7]; P<.0001.1 Among patients who were treated with E+R2, 74.5% achieved a complete response (CR) (n=95% CI: 68.5, 79.8) compared to a 43.3% CR rate among patients treated with R2 (n=95% CI: 37.0, 49.7).1 Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 88.1% of patients receiving E+R2 vs 62.2% with R2, the difference being primarily driven by higher rates of neutropenia (66.3% vs 37.8%) and infections (29.2% vs 13.4%).1 In the E+R2 group, CRS events were at a low grade, and all resolved eventually.1 Recently, EPKINLY in combination with R2 was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R FL.2 Fixed-Duration Venetoclax (BCL-2 Inhibitor) Regimens in Previously Untreated CLL Interim data will be showcased from the randomized, Phase 3 CLL17 trial (NCT04608318) conducted and presented by the German CLL Study Group (GCLLSG) comparing continuous ibrutinib (I) monotherapy (n=301) to fixed-duration venetoclax plus obinutuzumab (VO; n=303) and venetoclax plus ibrutinib (VI; n=305) for patients with previously untreated CLL.3 The study was designed to test non-inferiority of VO vs I and VI vs I.3 After a median follow-up of 34.2 months, the study met non-inferiority endpoints for the VO arm compared to I arm (HR 0.87, type-I-error adjusted CI [98.3%] 0.54-1.41) and for VI arm compared to I arm (HR 0.84, type-I-error adjusted CI [98.0%] 0.53-1.32).3 The 3-year PFS for VO, I and IV arms were 81.1%, 81.0% and 79.4% respectively.3 The most frequent adverse events (AEs) were infections and infestations (VO: 76.3%, VI: 80.2%, I: 79.9%), gastrointestinal disorders (VO: 59.7%, VI: 74.3%, I: 63.4%), and blood and lymphatic system disorders (VO: 59.0%, VI: 42.9%, I: 28.5%).3 Venetoclax plus ibrutinib is an investigational combination not approved by the FDA. Etentamig (Bispecific T-Cell Engager) in R/R MM and AL Results from a Phase 1b multi-arm, open-label study evaluating etentamig, a BCMAxCD3 bispecific T-cell engager, (NCT05259839) combined with pomalidomide and dexamethasone (POM+DEX) in 85 heavily pretreated (at least 3 prior lines of therapy) R/R multiple myeloma patients will be presented.4 Preliminary data from the dose escalation portion of the study (n=82) highlight that etentamig in combination with POM+DEX achieved an ORR of 81% and a very good partial response or better (≥VGPR) of 72% at median follow-up of 23 months (range: 1-33 months).4 In this heavily pretreated population, duration of response (DoR) were not reached at time of analysis. Most common grade 3/4 AEs were neutropenia (78%), anemia (28%) and thrombocytopenia (22%).4 Overall, these data support further exploration of the regimen in a randomized Phase 3 study.4 Additional preliminary data from the dose escalation study with etentamig monotherapy in R/R light chain AL will be showcased as an oral presentation. (NCT06158854) PVEK (Antibody Drug Conjugate) in Newly Diagnosed AML PVEK is a first-in-class antibody-drug conjugate comprised of a high-affinity anti-CD123 antibody and an indolinobenzodiazepine pseudodimer (IGN) payload. An oral presentation will showcase data from the dose expansion part of an open-label Phase 1b/2 study of PVEK combined with venetoclax and azacitidine (VEN + AZA) in newly diagnosed, CD123-positive AML patients (n=49) who are unfit for intensive chemotherapy (NCT04086264).5 The results show high CR rates of 63.3% with PVEK+VEN+AZA.5 The most common TEAEs (any grade) were neutropenia and thrombocytopenia (both at 69%), constipation (61%) and peripheral edema (51%).5 These data highlight the need to further evaluate this regimen in a randomized trial.5 A Biologics License Application (BLA) for PVEK was recently submitted to the FDA seeking approval for patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), a rare blood cancer.6 Details on key presentations at the ASH 2025 Congress are available below and the full abstracts are available here: Etentamig (ABBV-383) and PVEK are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. EPKINLY® (epcoritamab-bysp) and VENCLEXTA® (venetoclax) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Additional information on AbbVie clinical trials is available at . U.S. Prescribing Information for AbbVie Medicines EPKINLY® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory), after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after receiving 2 or more treatments. It is not known if EPKINLY is safe and effective in children. Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with follicular lymphoma (FL) may need to be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please click here for the Full Prescribing Information and Medication Guide. VENCLEXTA® (venetoclax) U.S. Uses and Important Safety Information Uses VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who: ‒ are 75 years of age or older, or ‒ have other medical conditions that prevent the use of standard chemotherapy. It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose. Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects. Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider. Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you: have kidney or liver problems. have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium. have a history of high uric acid levels in your blood or gout. are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA. are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away. are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose. What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA. The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet. The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for the Full Prescribing Information and Medication Guide. Globally, prescribing information varies; refer to the individual country product labels for complete information. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Falchi L, Nijland M, Huang H, et al. Primary Phase 3 results from the epcore FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma. Abstract 224 presented at the American Society of Hematology Congress 2025. Orlando, Florida. EPKINLY (epcoritamab-bysp) [package insert]. Copenhagen, Denmark: Genmab, 2025. Al-Sawaf O, Stumpf J, Zhang C, et al. Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial. Abstract 2071 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. Voorhees P, D'Souza A, Quach H, et al. Etentamig plus pomalidomide-dexamethasone combination therapy in relapsed or refractory multiple myeloma: A phase 1b dose-escalation and safety expansion study. Abstract 1875 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. Daver N, Advani A, De La Fuente Burguera A, et al. Efficacy and safety of pivekimab sunirine in combination with venetoclax plus azacitidine in unfit patients with newly diagnosed Acute Myeloid Leukemia. Abstract 2524 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie Inc. 21% more press release views with Request a Demo