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

Elahere secures full approval from FDA for types of ovarian cancer

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来源: Pharmaceutical Technology

The FDA has granted full approval to Elahere after it granted priority review in December 2023. Credit: Maxx-Studio via Shutterstock.

AbbVie’s monoclonal antibody Elahere (mirvetuximab soravtansine-gynx) has bagged full approval from the US Food and Drug Administration (FDA) for the treatment of certain types of ovarian cancer.

Elahere, an antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα), has received full approval for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for adult patients who have received one to three prior systemic treatment regimens.

AbbVie inherited the drug as part of a $10.1bn acquisition deal with ImmunoGen that was announced in November 2023. The FDA granted accelerated approval for the drug back in November 2022 for the indications listed above, with the agency granting priority review in December 2023.

The full approval is supported by the data from the Phase III MIRASOL trial (NCT04209855), where Elahere was compared to the 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, which is currently being investigated in Phase II trials. However, Elahere holds the first-to-market advantage. According to a consensus forecast on GlobalData’s Pharma Intelligence Center, Elahere is projected to generate $2.8bn in 2029, compared to $75m for farletuzumab ecteribulin in the same year.

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GlobalData is the parent company of Pharmaceutical Technology.

In the announcement accompanying the approval, AbbVie’s chief medical officer Roopal 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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