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Elahere secures full approval from FDA for types of ovarian cancer
2024-03-25
上市批准临床2期临床3期临床结果优先审批
The FDA has granted full approval to Elahere after it granted priority review in December 2023. Credit: Maxx-Studio via Shutterstock.
AbbVFDAs monoclonal antibody Elahere Elahereuximab soravtansine-gynx) has bagged full approval from the Maxx-Studio Drug Administration (FDA) for the treatment of certain types of ovarian cancer.
AbbViee, an antibody-drug conElahere(Amirvetuximab soravtansine-gynxor alpha (FRα), has received full approFood and Drug Administration (FDA)ive, platinum-resistant epithelial ovarovarian cancer tube, or primary peritoneal cancer for adult patients who have received one to three prior systemic treatment regimens.
Elahereinherited the drug as part of a $10.1bn acquisition deal with ImmunoGen that was announced in November 2023. The FDA granted FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancerFRαelerated approval for the drug back in November 2022 for the indications listed above, with the agency granting priority review in December 2023.
AbbViell approval is supported by the data from the Phase III MIRASOLImmunoGenCT04209855), where Elahere was compared toFDAe investigator’s choice of chemotherapy in patients with platinum-resistant ovarian cancer, whose tumours expressed high levels of FRα and who have been treated with up to three prior therapies. The trial met its primary endpoint of progression-free survival, with a 35% reduction in the risk of tumour or cancer progression in the Elahere arm compared to chemotherapy. Key secondary endpoints such as objective response rate and overall survival were also met.
Elahere faces competition from Bristol Myers Squibb and Eisai’s ADC farletuzumab ecteribulin, whiElahereurrently being investigated in Phase II trials. However, Elahere holds the fplatinum-resistant ovarian cancerng to a consensus forecast on GlobalData’FRαharma Intelligence Center, Elahere is projected to generate $2.8bn in 2029, compared to $75m for farletuzumab ecteribulin in the same year.tumourcancerElahere
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GlobalData is the parent company of Pharmaceutical Technology.
In the announcement accompanying the approval,Nodal Marginal Zone B-Cell Lymphomapal Thakkar said: “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 ADC approved in the US for this difficult-to-treat malignancy.”
The drug is currently being investigated in three other ovarian cancer trials, in combination with Roche’s Avastin (bevacizumab) in the Phase III GLORIOSA study (NCT05445778), as a monotherapy in the Phase II PICCOLO study (NCT05041257), and with carboplatin in another Phase II trial (NCT05456685).
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