ASH: Merck's Keytruda nabs speedy FDA review in non-Hodgkin lymphoma

Keytruda
The priority review designation is a boost for Keytruda, which had some setbacks this summer. (Image: Merck)

ATLANTAMerck’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 lymphomaand 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.

RELATED: Merck's Keytruda nabs first blood-cancer nod, but rare cancer decision has to wait

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.

Suggested Articles

Pfizer is doubling down on real-world data in HR-positive, HER2-negative breast cancer patients to boost its case for blockbuster Ibrance.

Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean even more on that strategy to save costs.

In a last-minute deal during North American trade talks, the Trump administration agreed to scrap rules protecting biologic drugs from copycat rivals.