Just a few months after Merck’s monster May for Keytruda, which featured three FDA approvals, the New Jersey drugmaker is back with another green light.
Friday, U.S. regulators gave the drug a go-ahead as a treatment for two types of recurrent or advanced gastric cancer in patients who've received at least two prior rounds of therapy. The accelerated approval comes based on tumor response rate and durability of response data, Merck said.
The win follows a late May priority review designation from the FDA, which capped off quite the month for Merck’s PD-1 blockbuster. Keytruda posted a trifecta of FDA nods, comprising approvals in front-line lung cancer, bladder cancer and microsatellite instability-high cancer.
Meanwhile, though, Merck sees more potential in the stomach cancer arena, where Keytruda recently posted additional positive data. Earlier this month at the European Society for Medical Oncology (ESMO) annual meeting, the pharma giant trumpeted results showing that, among PD-L1-positive patients new to therapy, about 69% responded to a Keytruda-chemo combo—as did 60% of all patients, regardless of PD-L1 status.
Merck isn’t the only immuno-oncology drugmaker looking to come up big in stomach cancer, though. Ono Pharmaceutical, partner of Merck archrival Bristol-Myers Squibb, said late last year that Opdivo had topped placebo at extending overall survival among chemo-intolerant patients or those who failed to respond to chemo.
Bristol wouldn’t cede the regulatory limelight to Merck on Friday, either. That same day, it said the FDA had approved Opdivo as a second-line treatment for the most common form of liver cancer.