ATLANTA—Merck’s quest to move Keytruda further into blood cancers hit a snag over the summer, but now, it’s back on track.
The FDA has accepted the New Jersey drugmaker’s application for the immuno-oncology star in previously treated primary mediastinal large B-cell lymphoma (PMBCL), a form of non-Hodgkin lymphoma—and it’s bestowed its priority review tag to the application to boot.
The designation lines up a speedy review for Keytruda as regulators sift through results from Merck’s Keynote-170 trial, which showed Keytruda could provoke a response in 41% of patients and a complete response in 24% of them. The data were presented Sunday at the American Society of Hematology annual meeting.
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If Merck can snag a go-ahead in PMBCL, it’ll be Keytruda’s second approval in blood cancer. Back in March, it won a green light to treat patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior treatment lines.
Lately, though, it’s had a tougher time; in July, after reviewing deaths in two Keytruda trials, the FDA put a pair of Merck studies on hold and stopped Keytruda dosing in a third. The moves dashed the drugmaker’s hopes for combining its checkpoint inhibitor with Celgene giants Pomalyst and Revlimid.
Keytruda has gone on a tear this year, grabbing a series of FDA blessings in areas including front-line lung cancer and bladder cancer. Most recently, it nabbed a stomach-cancer OK in September.