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- The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) - Data show that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35% - ELAHERE represents AbbVie's first approved solid tumor treatment following the recent acquisition of ImmunoGen
NORTH CHICAGO, Ill., March 22, 2024/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.
"The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.
ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator's choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FRα and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).
"As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that," said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.
ABOUT THE PHASE 3 MIRASOL TRIALMIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
Based on current results:
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About AbbVie in OncologyAt AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 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 AbbVieAbbVie'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 – 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, and changes to laws and regulations applicable to our industry. 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 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.
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