FDA approves mirvetuximab soravtansine-gynx (Elahere, …
WEBOn March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive,...
For ImmunoGen, persistence pays off as FDA clears ovarian cancer …
WEBNov 15, 2022 · The regulator’s decision late Monday makes the drug, known as Elahere, the first new treatment available for ovarian cancer in more than seven years. It’s also a conditional approval that ImmunoGen will have to maintain by confirming Elahere’s benefits in further testing.
U.S. Food and Drug Administration (FDA) Grants Full Approval for ...
WEBMar 22, 2024 · ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin...
FDA Grants Full Approval to Elahere for Patients With Epithelial ...
WEBMar 25, 2024 · The FDA granted accelerated approval to Elahere in November 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously administered one to three systemic treatment regimens. Image credit: nerthuz | stock.adobe.com.
ImmunoGen's Elahere delivers landmark ovarian cancer win
WEBMay 3, 2023 · In a pleasant surprise to ImmunoGen investors, Elahere slashed the risk of death by 33% compared with chemotherapy in certain patients with previously treated ovarian cancer, the Massachusetts...
Mirvetuximab Soravtansine-Gynx Approved for Ovarian Cancer
WEBApr 24, 2024 · Elahere is an antibody–drug conjugate made up of a monoclonal antibody called mirvetuximab attached to a highly potent chemotherapy drug called DM4. After being infused into patients, mirvetuximab seeks out and binds to FR-α on the surface of ovarian cancer cells.
ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ …
WEBNov 14, 2022 · ELAHERE™ is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
ImmunoGen’s Elahere Aces Confirmatory Trial, Poised to Win Full ...
WEBMay 4, 2023 · Wednesday, Massachusetts-based ImmunoGen released topline data showing its antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) met its primary outcome in the Phase III confirmatory MIRASOL trial, inducing significant improvements in progression-free and overall survival in platinum-resistant ovarian cancer.
ImmunoGen drug prolongs survival in advanced ovarian cancer
WEBJun 4, 2023 · The drug, called Elahere, is made by the biotech company ImmunoGen. It was granted conditional approval in the U.S. last November based on preliminary evidence showing it shrank tumors.
EMA Backs Approval of Elahere for Ovarian Cancer - Medscape
WEB2 days ago · Elahere was found to improve survival in patients with FR-alpha–positive, platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.