Merck follows Bristol's suit, pulling Keytruda's SCLC nod. Is the FDA's accelerated approval reckoning finally here?

Several cancer drugs cleared under the FDA accelerated approval program have remained on the market for years despite failing trials designed to confirm earlier-stage success. The FDA simply hasn’t acted in the face of those flops.

Critics have called out the agency for compromising its regulatory standards to no result. Until now.

In recent weeks, drugmakers suddenly began pulling indications for their immuno-oncology therapies after their failures in confirmatory trials. The latest? Merck & Co. for its megablockbuster PD-1 inhibitor Keytruda in small cell lung cancer (SCLC).