Late last year, Merck snagged two FDA priority review tags for Keytruda in one week, winning speedy regulatory reviews for the med in classical Hodgkin lymphoma (cHL) and microsatellite instability-high cancer (MSI-H). For now, though, the company has the green light to market the drug in just one of those arenas.
The New Jersey drugmaker has nabbed approval for its high-flying cancer-fighter in patients with refractory cHL, or those who have relapsed after three or more prior treatment lines. The go-ahead brings Keytruda’s list of approved indications to four, with cHL joining melanoma, non-small cell lung cancer and head and neck cancer.
An indication that won’t join that list, at least yet? MSI-H.
U.S. regulators announced Tuesday that they’d extended their decision date on that front to June 9. That new deadline will give them more time to review additional data and analyses that Merck only recently submitted, a move that auto-extended the PDUFA period.
While neither cHL nor MSI-H boast huge patient populations compared with more common cancer forms, both markets represented opportunities to go where Keytruda’s competitors haven’t gone before. While Bristol-Myers Squibb’s Opdivo—Keytruda’s fiercest rival—has a cHL nod, it’s approved only in patients whose cancer has returned or spread after an autologous stem cell transplant and treatment with Seattle Genetics’ Adcetris.
And with competition only expanding in some of the major indications—both Opdivo and Roche’s Tecentriq boast NSCLC indications, and AstraZeneca is working hard to grab one for candidate durvalumab—expanding Keytruda’s horizons is an important piece of Merck’s strategy.
That’s not to say Merck isn’t holding it’s own against that field. On the contrary, it’s got a serious lead in lung cancer, which analysts consider the ultimate immuno-oncology prize. After initially trailing Opdivo, Keytruda got the chance to zoom ahead when Bristol’s med flopped a first-line monotherapy trial; Keytruda followed up with an FDA approval in that space, and now it’s first in line to win the agency’s favor for its front-line chemo combo, too.