The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly.
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Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.
The ADC comprises an FRα-binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.
Elahere is said to be the first ADC to receive FDA approval for platinum-resistant disease.
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ImmunoGen president and CEO Mark Enyedy said: “With an indication for use regardless of prior treatment with Avastin, we believe Elahere is positioned to become the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer.
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By GlobalData“Elahere’s accelerated approval is a testament to the decades of work dedicated to developing the next generation of ADCs and marks ImmunoGen’s transition to a fully-integrated oncology company and the start of an exciting new chapter for us as a leader in the development and commercialisation of innovative oncology products.”
Continued approval for the ADC is subject to validation of its clinical benefit in a confirmatory trial.
The confirmatory, randomised MIRASOL trial has concluded subject enrolment with top-line findings anticipated early next year.
In February, the company signed a licencing agreement under which Eli Lilly and Company obtained exclusive rights to conduct the research, development and marketing of ADCs.
