The US Food and Drug Administration (FDA) has granted priority review for the full approval of the antibody drug conjugate, Elahere (mirvetuximab soravtansine-gynx) and has set a Prescription Drug User Fee Act (PDUFA) action date of 5 April 2024.
Elahere was a central element in the $10.1bn ImmunoGen acquisition deal announced by AbbVie last week (30 November). AbbVie expects the acquisition to complete in mid-2024.
Elahere is an antibody drug conjugate (ADC) that targets folate receptor alpha (FRα). In November 2022, it was granted accelerated approval as the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for patients who have received one to three prior systemic treatment regimens.
The latest supplemental Biologics License Application (sBLA) for Elahere is supported by the data from the Phase III MIRASOL trial, which will allow for the accelerated approval to be converted to a full approval.
ImmunoGen reported $105.2m in net sales for Elahere in Q3 2023, and the therapy is forecasted to generate $1.43bn in global sales in 2029, as per GlobalData analysis.
GlobalData is the parent company of Pharmaceutical Technology.
The MIRASOL trial met its primary endpoint demonstrating a 35% reduction in the risk of tumour progression or death in the Elahere treatment group compared to the chemotherapy arm, as per a 4 June press release. The median overall survival was 16.46 months and 12.76 months for the Elahere and chemotherapy groups, respectively, as of 6 March.
The objective response rate by investigator assessment was 42.3% in Elahere arm, with 12 complete responses, compared to 15.9% and no complete responses in the chemotherapy arm. During the trial, 9% and 16% of the participants on the Elahere and chemotherapy arms discontinued the study due to treatment-emergent adverse events.
ADCs have been a growing area of interest in recent years, with multiple companies out-licencing and partnering to develop these therapies. In October, Eli Lilly agreed to acquire French biotech Mablink, which had a proprietary ADC development technology.
