Tuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients.
Regulators green-lighted the immuno-oncology star as monotherapy in patients whose tumors bear the biomarker PD-L1 and in combination with a commonly used chemo regimen in patients regardless of PD-L1 status.
The regulatory wins follow a quick review from the agency, which bestowed its priority designation on Keytruda back in February.
FDA staffers based the speed-up on data showing that that, when facing off against a standard-of-care regimen commonly referred to by the name “Extreme,” Keytruda could lower the risk of death by 22% in PD-L1 positive patients. And when paired with chemo, Keytruda slashed the risk of death by 23% regardless of patients’ PD-L1 status.
With the OKs, Keytruda becomes the first in its class of PD-1/PD-L1 drugs into the first-line head and neck cancer market. The go-ahead unlocks potential use in more than 65,000 patients diagnosed each year in the U.S., Merck said.
It also puts Keytruda ahead of archrival Opdivo from Bristol-Myers Squibb, which is cleared only for patients who have already failed on chemo—meaning those who start out on Keytruda instead of chemo won’t be eligible for Opdivo treatment later.
And the last thing Bristol-Myers needs is to trail Keytruda in another therapy area. It’s already ceded the lead in lung cancer, immuno-oncology’s most lucrative market—and Keytruda has run away with it. And in kidney cancer, an area that’s been historically important to Opdivo sales, Merck recently arrived on the scene with a competing combo approval.