FDA’s speed kills Agenus’s PD-1 application

In yet another controversy over PD-1s, Agenus announced Friday it is complying with an FDA request to withdraw a BLA seeking accelerated approval for its balstilimab as monotherapy in second-line cervical cancer.

FDA’s request to Agenus Inc. (NASDAQ:AGEN) was prompted by the agency’s granting of full approval on Oct. 13 to Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) as a single agent for second-line treatment of cervical cancer. The approval is for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1. ...