AbbVie Gets CHMP Backing for Elahere in Ovarian Cancer
WEB3 days ago · Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab …
WEB3 days ago · ELAHERE® (mirvetuximab soravtansine-gynx) U.S. INDICATION and IMPORTANT SAFETY INFORMATION ... Some statements in this news release are, or may be considered, forward-looking statements for ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab …
WEB3 days ago · 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 ...
U.S. Food and Drug Administration (FDA) Grants Full Approval for ... - News
WEBMar 22, 2024 · 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 | European Medicines Agency (EMA)
WEB3 days ago · Elahere will be available as 5 mg/ml concentrate for solution for infusion. The active substance of Elahere is mirvetuximab soravtansine, an antineoplastic monoclonal antibody-drug conjugate (ATC code: L01FX26). Mirvetuximab is made up of an antibody that binds to the FRα receptor expressed on the surface of ovarian cancer cells and DM4, a ...
AbbVie to Acquire ImmunoGen, including its Flagship Cancer ... - News
WEBNov 30, 2023 · ELAHERE ® is a first-in-class antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer; ImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines …
Mirvetuximab Soravtansine-Gynx Approved for Ovarian Cancer
WEBApr 24, 2024 · Platinum-resistant ovarian cancer has proven difficult to treat, but with the Food and Drug Administration’s recent full approval of mirvetuximab soravtansine-gynx (Elahere), some people in this situation now have a new treatment option.
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WEBJun 6, 2024 · Mirvetuximab soravtansine approved under the brand name ELAHERE® in the United States has received regulatory approval in adults 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.
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...
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,...