Elahere FDA Approval History - Drugs.com
WEBJun 8, 2024 · FDA Approved: Yes (First approved November 14, 2022) Brand name: Elahere. Generic name: mirvetuximab soravtansine-gynx. Previous name: mirvetuximab soravtansine. Dosage form: Injection. Company: ImmunoGen, Inc. Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer.
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,...
FDA grants accelerated approval to mirvetuximab soravtansine …
WEBOn November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha...
Drug Trial Snapshots: ELAHERE | FDA
WEBOct 24, 2023 · The FDA approved ELAHERE based on evidence from one clinical trial of 106 patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer...
Mirvetuximab Soravtansine-Gynx Approved for Ovarian Cancer
WEBApr 24, 2024 · Elahere is an antibody–drug conjugate that targets FR-α, a protein overexpressed in many ovarian cancers. It was approved by FDA in 2024 based on a trial that showed it improved survival and tumor shrinkage …
U.S. Food and Drug Administration (FDA) Grants Full Approval for ...
WEBMar 22, 2024 · 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...
ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ …
WEBNov 14, 2022 · ELAHERE is a first-in-class antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα) in ovarian cancer. It is the first ADC approved by FDA for platinum-resistant disease and has a companion diagnostic, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
U.S. Food and Drug Administration (FDA) Grants Full Approval for ...
WEBMar 22, 2024 · Elahere is an antibody-drug conjugate that targets folate receptor alpha (FRα) and extends overall survival in platinum-resistant ovarian cancer patients. It was granted full approval by the FDA in March 2024 based on the MIRASOL Phase 3 …
Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant …
WEBDec 6, 2023 · MIRV is an antibody–drug conjugate that has been approved by the FDA for FRα-expressing, platinum-resistant ovarian cancer. 22 We report the results of efficacy and safety assessments in the ...
ELAHERE® Shows Overall and Progression-Free Survival Benefit …
WEBSep 28, 2023 · In November 2022, the US Food and Drug Administration (FDA) granted accelerated approval for ELAHERE for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens based on …