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You want to talk about a rug pull, I thick AGEN qualifies

Agenus withdraws cervical cancer application, and a behind the scenes David vs. Big Pharma regulatory battle is revealed
by Annalee Armstrong |
Oct 22, 2021 8:00am
Agenus argues that Merck didn’t have to submit any extra data to support the second-line approval. (Merck & Co.)
Agenus’ cervical cancer drug balstilimab seemed on its way to FDA approval, but the biotech is now pulling the application after the agency granted full approval to Merck’s Keytruda in the same indication.
The biotech said in a statement released today that a filing for the approval of balstilimab is being voluntarily withdrawn, but according to a source with knowledge of the decision, the FDA pushed Agenus into a corner and recommended that the request be retracted.
Agenus Chairman and CEO Garo Armen, Ph.D., has urged the FDA’s Richard Pazdur, M.D., to intervene and allow the company’s therapy to be reviewed under the accelerated pathway, according to a document seen by Fierce Biotech.
This one gets into the weeds a bit, so stay with me here: Keytruda was granted accelerated approval in second line cervical cancer back in 2018. Earlier this month, the drug was moved up to the first-line setting as well. At that time, the FDA also confirmed that the accelerated approval in the second-line setting had been converted to a full approval. Merck submitted data from the first-line setting to support the second-line decision.

RELATED: Merck bags imperfect immunotherapy first with Keytruda cervical cancer approval

This is standard practice in the industry. New drugs often start out as later-line therapies before moving up to the first-line setting, and data from the earlier-line treatment can be used to support the later-line settings.
If you’re still with me, Agenus’ complaint is this: once the full approval was granted to Keytruda in the second-line setting, “the window for accelerated approval of balstilimab closed,” according to a company press release. The agency acted four months ahead of the goal date for Merck’s application. Had the FDA stuck with that goal, Agenus would have had a shot at securing the coveted accelerated approval...

https://www.fiercebiotech.com/biotech/agenus-withdraws-cervical-cancer-application-for-balstilimab-after-fda-fully-authorizes?oly_enc_id=4891B5384067C3X