Agenus withdraws cervical cancer BLA, regulatory drama brews

Oct. 22, 2021

Agenus has announced a "strategic decision" to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor for cervial cancer, following the full approval of Merck’s Keytruda — which came four months earlier than the FDA goal date.

According to Massachusetts-based Agenus, the withdrawal came at the recommendation of the FDA. "The U.S. FDA no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw," the company said in a press release.

The FDA can grant drugs accelerated approval when they address “a serious or life-threatening disease or condition.” For Agenus, this means that their drug (balstilimab) — which had a target action date of Dec. 16, 2021 — would have to prove it could improve upon the already existing treatment — which is now Keytruda.

The backstory? Keytruda was granted accelerated approval by the FDA in second-line cervical cancer in 2018. Earlier this month, Merck announced that Keytruda was approved as a first-line treatment for cervical cancer patients. At the same time, the FDA converted the accelerated approval of Keytruda in the second-line setting to a full approval based on confirmatory data from KEYNOTE-826. 

Essentially, Keytruda’s full approval blocked Agenus’ chances of accelerated approval.

In an Oct. 18 letter to Richard Pazdur, head of FDA’s oncology center of excellence, shared with media sources, Agenus CEO Garo Armen wrote, “This seemingly-quick approval of pembrolizumab hours before Agenus’s LCM [late-cycle meeting] suggests that FDA may have afforded special consideration to Merck, the sponsor of the pembrolizumab application.” 

Agenus says it will discontinue its ongoing confirmatory trial (BRAVA) in the specific cervical cancer population. However, given the clinical benefit demonstrated by balstilimab, the drugmaker plans to launch expanded access programs to give patients and doctors access to the treatment in several countries, including the US, pending regulatory processes.