It’s good to be Merck these days. In a month that's featured three FDA approvals for Keytruda, the immuno-oncology med has netted a speedy review for the therapy in stomach cancer.
On Tuesday, U.S. regulators bestowed their priority tag on the Merck drug, hastening their review of the product as a treatment for two types of recurrent or advanced gastric cancer in patients who've received at least two rounds of chemo. The FDA will hand down an approval decision by September 22, it said.
The New Jersey drugmaker is hoping the new indication—specifically for gastric or gastroesophageal junction adenocarcinoma—can help keep the positive regulatory news coming for its immuno-oncology star. Tuesday, Keytruda scored an approval in microsatellite instability-high cancer, a rare tumor type identified with genetic testing. Last week, Keytruda landed a bladder cancer nod to join its rivals in that field. And less than two weeks ago, it solidified its lead in non-small cell lung cancer (NSCLC) with a front-line Keytruda-chemo combo approval.
While Keytruda has managed to muscle past heavy competition already, namely in the all-important lung cancer field, the competition in immuno-oncology is more plentiful than ever. Five checkpoint inhibitors—Keytruda; Opdivo; Roche’s Tecentriq; Pfizer and Merck KGaA’s Bavencio; and AstraZeneca’s Imfinzi—now boast at least one FDA-approved indication, and Keytruda will have to take on all four of those rival meds as it enters the bladder cancer arena.
It may not fly solo in gastric cancer forever, either. Opdivo put up positive data in November in that cancer, and Bristol-Myers' partner, Ono Pharmaceuticals, has already filed for regulatory approval in Japan based on that data. Bristol-Myers hasn't said whether it plans to do the same in the U.S. Pfizer and Merck KGaA are studying their med in gastric cancer as well, but those trials are at an early stage.
Editor's note: This story has been updated to include news of Keytruda's approval in microsatellite instability-high cancer.