AbbVie Gets CHMP Backing for Elahere in Ovarian Cancer
WEB1 day 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 …
WEB12 hours 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 ...
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WEB1 day ago · ELAHERE® (mirvetuximab soravtansine-gynx) U.S. INDICATION and IMPORTANT SAFETY INFORMATION ... 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 ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab …
WEB12 hours 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 purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses ...
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.
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.
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 …
Elahere | European Medicines Agency (EMA)
WEB1 day 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 ...
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...
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