Bendamustine Hydrochloride

AstraZeneca advances its ambition to redefine haematology care with new data from its diverse pipeline and portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, 6-9 December 2025. This year’s ASH congress will feature the Company’s largest presence to date, with 65 abstracts across eight approved and investigational medicines, including 15 oral presentations. Key presentations include: Phase I trial of surovatamig: Updated results at three-year follow up from the ongoing first-in-human trial of surovatamig,aCD19xCD3 T-cell engager, in relapsed/refractory (R/R) follicular lymphoma (FL) (Oral Abstract #1005). DURGA-1 Phase Ib/II study: Initial data for AZD0120 in patients with R/R multiple myeloma (MM). AZD0120 is an investigational BCMAxCD19 chimeric antigen receptor T-cell (CAR T) therapy(Oral Abstract #269). ECHO Phase III trial: Results after 50 months of follow up evaluating Calquence (acalabrutinib)plus bendamustine and rituximab in the first-line treatment of mantle cell lymphoma (MCL) (Oral Abstract #885). ALXN1210-TMA-314 Phase III trial: Additionalresults from the open-label trial evaluating Ultomiris (ravulizumab) in paediatric patients with haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) (Oral Abstract #1052). Anas Younes, Senior Vice President, Haematology R&D and Chief Medical Officer, AstraZeneca, said: “We are advancing a broad pipeline of investigational therapies with the potential to redefine patient care across multiple types of blood cancer. At ASH, we are sharing meaningful progress with early efficacy and safety data for AZD0120, our first cell therapy, in multiple myeloma, and for surovatamig, a novel T-cell engager, in B-cell malignancies.” Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: “At ASH, we look forward to demonstrating how pioneering science can drive meaningful advances for people living with rare haematologic conditions. New data on Ultomiris, including Phase III results in paediatric patients with HSCT-TMA, will show clinically meaningful overall survival and improved outcomes, highlighting our ongoing pursuit to realise the full potential of our medicines and their impact on treating rare conditions.” Additional highlights include: SYRUS Phase I/II trial: Updated safety and efficacy data for surovatamig in adolescent and adult patients with R/R B-cell acute lymphoblastic leukaemia (Abstract #3345) Phase I trial of surovatamig: Initial efficacy and safety data for surovatamig in R/R diffuse large B-cell lymphoma (Abstract #5514) AZD0120: Follow-up data from two investigator-initiated trials (IIT) in China evaluating AZD0120 as a first-line therapy in high-risk, newly diagnosed MM (Oral Abstract #258). TrAVeRse Phase II trial: Preliminary results evaluating Calquence plus venetoclax and rituximab in treatment-naïve MCL patients (Oral Abstract #884). AMPLIFY Phase III trial: Exploratory analyses supporting the safety and efficacy profile of Calquence in first-line chronic lymphocytic leukaemia, with new subgroup data evaluating the impact of prognostic mutations on clinical outcomes (Poster Abstract #3898). ALPHA Phase III trial: Sub-analysis of results evaluating Voydeya (danicopan) as add-on to Ultomiris or Soliris (eculizumab) in adults with paroxysmal nocturnal haemoglobinuria (PNH) and clinically significant extravascular haemolysis, including in patients with advanced age (Oral Abstract #949). Ultomiris: Real-world evidence highlighting the impact of Ultomiris in certain patient subgroups across approved indications, including in pregnant patients (Poster Abstracts #6238 and #4458). Key presentations during the 67th ASH Annual Meeting and Exposition Lead Author Abstract Title Presentation Details (ET) Lead Author Awan, F et al. Abstract Title Budget Impact of Fixed Duration Acalabrutinib in Combination with Venetoclax in Previously Untreated Chronic Lymphocytic Leukemia Patients in the United States Presentation Details (ET) Abstract #2627 Poster Abstract Session Session 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster I 6 December 2025 5:30 PM – 7:30 PM Lead Author Cheah, C et al. Abstract Title Analysis of predictive factors for POD24 in patients with previously untreated mantle cell lymphoma receiving bendamustine-rituximab with or without acalabrutinib in the Phase 3 ECHO trial Presentation Details (ET) Abstract #3578 Poster Abstract Session Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II 7 December 2025 6:00 PM – 8:00 PM Lead Author Ghia, P et al. Abstract Title Impact of prognostic mutations on outcomes with fixed-duration acalabrutinib-venetoclax combinations versus chemoimmunotherapy: An exploratory analysis from AMPLIFY Presentation Details (ET) Abstract #3898 Poster Abstract Session Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II 7 December 2025 6:00 PM – 8:00 PM Lead Author Hawkes, E et al. Abstract Title Acalabrutinib plus venetoclax and rituximab in patients with treatment-naive (TN) mantle cell lymphoma (MCL): Results from the phase 2 TrAVeRse study Presentation Details (ET) Abstract #884 Oral Abstract Session Session 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL 8 December 2025 3:00 PM – 03:15 PM Lead Author Hou, J-Z et al. Abstract Title Real-world incidence of treatment-emergent (TE) cardiovascular (CV) events among chronic lymphocytic (CLL)/small lymphocytic lymphoma (SLL) patients receiving acalabrutinib (acala) or zanubrutinib (zanu) monotherapy Presentation Details (ET) Abstract #4506 Poster Abstract Session Session 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II 7 December 2025 6:00 PM – 8:00 PM Lead Author Seymour, JF et al. Abstract Title A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the Phase 3 AMPLIFY trial Presentation Details (ET) Abstract #2118 Poster Abstract Session Session 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I 6 December 2025 5:30 PM – 7:30 PM Lead Author Wang, ML et al. Abstract Title Time to third-line treatment after bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: Updated analysis of the phase 3 ECHO trial after 50 months of follow-up Presentation Details (ET) Abstract #885 Oral Abstract Session Session 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Single Agent and Combination therapy for MCL 8 December 2025 3:15 PM – 3:30 PM Ultomiris (ravulizumab) Ultomiris (ravulizumab) Schoettler, M et al. Ultomiris (ravulizumab) Outcomes in pediatric patients with HSCT-TMA treated with ravulizumab Ultomiris (ravulizumab) Abstract #1052 Oral Abstract Session Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Outcomes, toxicities and late effects 8 December 2025 4:45 PM – 05:00 PM Ultomiris (ravulizumab) Chaudhury, S et al. Ultomiris (ravulizumab) Organ dysfunction in pediatric patients with HSCT-TMA treated with ravulizumab Ultomiris (ravulizumab) Abstract #4266 Poster Abstract Session Session 723. Allogeneic Transplantation: Long-term Follow-up, Complications, and Disease Recurrence: Poster II 7 December 2025 6:00 PM – 8:00 PM Ultomiris (ravulizumab) Sherrard, H et al. Ultomiris (ravulizumab) Safety of ravulizumab use in pregnancy: Insights from a global pharmacovigilance analysis Ultomiris (ravulizumab) Abstract #4458 Poster Abstract Session Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II 7 December 2025 6:00 PM – 8:00 PM Ultomiris (ravulizumab) Gandhi, S et al. Ultomiris (ravulizumab) Real-world analysis of ravulizumab safety and effectiveness in advanced age patients with paroxysmal nocturnal hemoglobinuria: Insights from the international PNH registry Ultomiris (ravulizumab) Abstract #6238 Poster Abstract Session Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III 8 December 2025 6:00 PM – 8:00 PM Fasenra (benralizumab) Fasenra (benralizumab) Klion et al. Fasenra (benralizumab) Efficacy and safety of benralizumab in patients with hypereosinophilic syndrome: Results from the Phase 3 natron study Fasenra (benralizumab) Abstract #79 Oral Abstract Session Session 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Expanding the Therapeutic and Prognostic Landscape in Myeloproliferative Neoplasms, Mastocytosis and Hypereosinophilic Syndrome 06 December, 2025 9:30 AM - 9:45 AM Fasenra (benralizumab) Klion et al. Fasenra (benralizumab) Patient perspectives on the burden of hypereosinophilic syndrome: Results from the Phase 3 natron interview sub-study Fasenra (benralizumab) Abstract #4465 Poster Presentation Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster II 07 December, 2025 6:00 PM - 8:00 PM Voydeya (danicopan) Voydeya (danicopan) Kulasekararaj, A et al. Voydeya (danicopan) Danicopan add-on therapy demonstrates positive efficacy and safety outcomes in advanced age adults with paroxysmal nocturnal hemoglobinuria and clinically significant extravascular hemolysis: A sub-analysis of the phase 3 ALPHA trial Voydeya (danicopan) Abstract #949 Oral Abstract Session Session 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Antithrombotic Roulette: Balancing Risk, Cost, and Care 8 December 2025 2:45 PM – 03:00 PM Surovatamig Surovatamig Aldoss, I et al. Surovatamig Safety and efficacy of surovatamig (AZD0486) in adolescent and adult patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Updated results from the Phase 1/2 SYRUS study Surovatamig Abstract #3345 Poster Abstract Session Session 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster II 7 December 2025 6:00 PM – 8:00 PM Surovatamig Cheah, C et al. Surovatamig SOUNDTRACK-B: A Phase 2 single-arm study to evaluate the efficacy and safety of surovatamig (AZD0486) in relapsed or refractory B-cell Non-Hodgkin lymphoma Surovatamig Abstract #3747 (TiP) Poster Abstract Session Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster II 7 December 2025 6:00 PM – 8:00 PM Surovatamig Hou, JZ et al. Surovatamig Three-year follow-up of the Phase 1 first-in-human study investigating surovatamig, a novel CD19xCD3 T-cell engager, in patients with relapsed/refractory (R/R) follicular lymphoma (FL) Surovatamig Abstract #1005 Oral Abstract Session Session 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological - Follicular Lymphoma 8 December 2025 5:00 PM – 5:15 PM Surovatamig Kim, TM et al. Surovatamig Surovatamig (AZD0486), a CD19xCD3 T-cell engager (TCE), demonstrates high rate of minimal residual disease (MRD)-negative complete responses in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including in patients who previously progressed on CD20 TCE and CD19 CAR T-cell therapies Surovatamig Abstract #5514 Poster Abstract Session Session 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III 8 December 2025 6:00 PM – 8:00 PM AZD0120 AZD0120 Du, J et al. AZD0120 A dual targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120) as first-line therapy for newly diagnosed multiple myeloma AZD0120 Abstract #258 Oral Abstract Session Session 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma 6 December 2025 2:15 PM – 2:30 PM AZD0120 Richard, S et al. AZD0120 Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, in relapsed/refractory multiple myeloma: Preliminary results from the DURGA-1 Phase 1b/2 study AZD0120 Abstract #269 Oral Abstract Session Session 704. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma 6 December 2025 3:00 PM – 3:15 PM AZD0120 Feng, J et al. AZD0120 One-year follow-up of CD19/BCMA dual-targeting FasTCAR-T GC012F (AZD0120) therapy in patients with refractory systemic lupus erythematosus AZD0120 Abstract #2384 Poster Abstract Session Session 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I 6 December 2025 5:30 PM – 7:30 PM AZD0120 Lentzsch, S et al. AZD0120 ALACRITY: A Phase 1b/2 Study of AZD0120 (BCMA/CD19 CAR-T cell therapy) in Participants with Relapsed or Refractory Light Chain Amyloidosis (AL) AZD0120 Abstract #8236 ePublication 3 November 2025 AZD4512 AZD4512 Han, H et al. AZD4512 AZD4512: A novel CD22-directed antibody-drug conjugate for the treatment of b-cell malignancies AZD4512 Abstract #3296 Poster Abstract Session Session 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II 7 December 2025 6:00 PM – 8:00 PM Notes AstraZeneca in haematology AstraZeneca is pushing the boundaries of science to redefine care in haematology. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases through innovative medicines and approaches that are shaped by insights from patients, caregivers and physicians. In addition to our marketed products, we are spearheading the development of novel therapies designed to target underlying drivers of disease across multiple scientific platforms. Our acquisitions of Alexion, with expertise in rare, non-malignant blood disorders, and Gracell Biotechnologies Inc., pioneers of autologous cell therapies, expand our haematology pipeline and enable us to reach more patients with high unmet needs through the end-to-end discovery, development and delivery of novel therapies. AstraZeneca in cell therapy AstraZeneca’s ambition is to realise the full potential of cell therapies. It is focused on empowering the immune system to attack cancers, reset the underlying drivers of immune-mediated diseases to return patients to health, and provide transformative solutions with curative potential for people living with rare diseases. To achieve this, the Company is building world-class cell therapy capabilities and advancing a broad pipeline of cell therapies, enabled by technologies including chimeric antigen receptor T-cells (CAR T), T-cell receptor therapies (TCR T) and CAR T regulatory (CAR Tregs) cells. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. Alexion Alexion, AstraZeneca Rare Disease, is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities. As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. Oncology Corporate and financial

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.Full prescribing information for Jaypirca will be posted here.Efficacy and SafetyEfficacy was evaluated in BRUIN-CLL-321 (NCT 04666038), a randomized, open-label, active-controlled trial. The trial randomized 238 patients who were previously treated for CLL/SLL, including a covalent BTK inhibitor. Patients previously treated with a non-covalent BTK inhibitor were not permitted. Patients were randomized (1:1) to receive either pirtobrutinib or investigator’s choice of idelalisib plus a rituximab product (IR) or bendamustine plus a rituximab product (BR). Crossover to JAYPIRCA monotherapy was permitted for patients in the investigator’s choice arm after confirmed disease progression.The primary efficacy outcome measure was progression-free survival (PFS), as assessed by an independent review committee using 2018 iwCLL criteria. Median PFS was 11.2 months (95% CI: 9.5, 11.4) in the pirtobrutinib arm and 8.7 months (95% CI: 7.2, 10.2) in the investigator’s choice of IR/BR arm (Hazard ratio 0.58 [95% CI: 0.38, 0.89]; p-value 0.0105). Of the 119 patients in the investigator’s choice arm, 50 crossed over to receive JAYPIRCA therapy. At an updated analysis with a median follow-up time of 19.8 months, the HR for overall survival (OS) was 1.09 (95% CI: 0.68, 1.75).The prescribing information includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrythmias, secondary primary malignancies, hepatotoxicity, and embryo-fetal toxicity.Recommended DosageThe recommended pirtobrutinib dose is 200 mg orally once daily until disease progression or unacceptable toxicity.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.Pirtobrutinib received orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.