Mirvetuximab soravtansine

AbbVie plans to launch its ovarian cancer drug Elahere (mirvetuximab soravtansine-gynx) in the UK at the same list price charged in the US, but its availability will hinge on negotiations with the country's cost watchdog.The antibody-drug conjugate, granted full approval in the US in March 2024 and greenlit by EU regulators eight months later, targets FRɑ-positive, platinum-resistant ovarian cancer.The UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved Elahere this past July. Discussions are under way with the National Institute for Health and Care Excellence (NICE), which will determine whether the NHS should reimburse Elahere.In the US, Elahere carries a wholesaler acquisition cost of about $6782 per 100 mg/20 mL vial, meaning a single treatment cycle – typically requiring multiple vials – can cost tens of thousands of dollars. AbbVie said the US-level list price "reflect[s] the advanced innovation and value of the treatment.”The company's stance comes on the heels of Bristol Myers Squibb announcing last week that it will introduce its schizophrenia drug Cobenfy (xanomeline/trospium chloride) in the UK at the same list price it charges in the US.The pricing push comes as President Donald Trump threatens to enforce a "most-favoured nation" policy requiring US drug prices to match the lowest levels paid by peer countries. AbbVie was among 17 drugmakers that received letters from the White House in July seeking "binding commitments" by a Sept. 29 deadline to lower US drug prices."Scientific progress in treating ovarian cancer and other serious diseases requires a collaborative approach among all developed nations," remarked Jeff Stewart, AbbVie's chief commercial officer, in a release Monday. "Developed markets must recognise and support the value that innovative therapies bring to patients and societies to help ensure sustainable access and continued investment in medical innovation."

Oncology The list price will be consistent with the United States to reflect the value of the innovation AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the United States NORTH CHICAGO, Ill., Sept. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced plans to launch ELAHERE® (mirvetuximab soravtansine-gynx) in the U.K. at a list price equal to the U.S., reflecting the advanced innovation and value of the treatment for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.1 ELAHERE is the first-and-only approved FRα-directed antibody drug conjugate (ADC) medicine. "Scientific progress in treating ovarian cancer and other serious diseases requires a collaborative approach among all developed nations," said Jeff Stewart, executive vice president and chief commercial officer, AbbVie. "Developed markets must recognize and support the value that innovative therapies bring to patients and societies to help ensure sustainable access and continued investment in medical innovation so that patients everywhere benefit from the next generation of therapies." AbbVie is in discussions with the National Institute for Health and Care Excellence (NICE) to ensure that ELAHERE, which will address a significant unmet need among women suffering from ovarian cancer, is valued fairly. The value given to ELAHERE will determine the ability to launch in the U.K. Ovarian cancer is one of the leading causes of death from gynecological cancer worldwide.2 More than 200,000 women die with the disease globally every year.2 ELAHERE is the first new treatment in 10 years to be licensed for the treatment of women in the U.K. with platinum-resistant ovarian cancer. The European Commission granted approval of ELAHERE in November 2024 and was granted full FDA approval in the U.S. in March 2024. In July, the Medicines and Healthcare products Regulatory Agency (MHRA) approved ELAHERE, reinforcing that enabling access to high-quality, safe and effective medical products is a priority.3 About ELAHERE® (mirvetuximab soravtansine-gynx) ELAHERE is a first-in-class antibody drug conjugate (ADC) composed of a folate receptor alpha binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Mirvetuximab soravtansine (approved under the brand name ELAHERE®) was granted approval by the European Commission in November 2024, and was granted full FDA approval in the United States in March 2024. Marketing authorization submissions for mirvetuximab soravtansine are under review in multiple other countries. ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION What is ELAHERE? ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who: have not responded to or are no longer responding to treatment with platinum-based chemotherapy and have received 1 to 3 prior types of chemotherapy. Your healthcare provider will perform a test to make sure that ELAHERE is right for you. It is not known if ELAHERE is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about ELAHERE? ELAHERE can cause serious side effects, including: Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes. Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems. Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider. Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider. What should I tell my healthcare provider before receiving ELAHERE? Tell your healthcare provider about all of your medical conditions, including if you: have vision or eye problems. have numbness or tingling in your hands or feet. have liver problems. are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE. Patients who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE. You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE. are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE. Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE. You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects. What are the possible side effects of ELAHERE? ELAHERE can cause serious side effects, including: Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes. Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain. Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness. The most common side effects and abnormal labs of ELAHERE include: • increased liver enzymes in the blood • feeling tired • blurred vision • nausea • diarrhea • stomach-area (abdominal) pain • changes in the cornea (part of the eye) • peripheral neuropathy • muscle, bone, or joint pain • decreased red or white blood cell counts • decreased platelets • decreased magnesium level in the blood • dry eye • constipation • vomiting • decreased albumin level in the blood • decreased appetite Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects. These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. Please see Full Prescribing Information, including Boxed WARNING and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. 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 http://www.abbvie.com/oncology. 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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. 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. Global Media: Marianne Ostrogorski +1 (224) 240-6336 marianne.ostrogorski@abbvie.com Investors: Liz Shea +1 (847) 935-2211 Liz.Shea@abbvie.com References 1ELAHERE. Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf. 2WHO International Agency for Research on Cancer. GLOBOCAN 2022. Cancer Today. Absolute numbers, Mortality, Females, age [0-74], in 2022. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. 3Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer. https://www.gov.uk/government/news/mirvetuximab-soravtansine-approved-to-treat-adult-patients-who-have-ovarian-fallopian-tube-or-primary-peritoneal-cancer. SOURCE AbbVie