Agenus pulls BLA for fast approval of balstilimab

US immune-oncology focussed biotech Agenus (Nasdaq: AGEN) said Friday it has withdrawn its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor, following which the company’s shares close down 22% at $4.01.

The decision to withdraw the BLA as a potential second-line treatment for cervical cancer does not change the development plans for balstilimab combinations, the company said.

Following the full approval of Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab), announced four months earlier than the FDA goal date, the US Food and Drug Administration no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021. As part of the BLA review process, Agenus successfully completed three FDA inspections with no cited issues, concerns, or Form-483s.