Merck’s Keytruda has nabbed its second FDA priority review tag of the week—and it’s one that’ll help it gain ground on archrival Opdivo from Bristol-Myers Squibb.
Thursday, the New Jersey drugmaker announced that U.S. regulators had granted the immuno-oncology star the speedy review as a treatment for patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of treatment. With the boost, Merck should have a verdict from the agency by March 15 of next year.
That means Keytruda will also get a quicker shot at challenging Opdivo in the cHL arena. Opdivo won its own indication in the disease--as a treatment for cHL patients whose disease has returned after autologous hematopoietic stem cell transplantation and post-transplantation treatment with Seattle Genetics’ Adcetris—in May, and it followed up with a European approval late last month.
Keytruda and Opdivo have been duking it out since late 2014, when they picked up their first FDA approvals in advanced melanoma. Since then, Opdivo has shot out to a lead when it comes to number of indications, but Keytruda has snagged the most lucrative of the bunch with a first-line monotherapy nod in non-small cell lung cancer.
The latest FDA action extends what was a fruitful November for both drugmakers. Earlier this week, Keytruda landed a priority distinction for the treatment of previously treated patients with advanced microsatellite instability-high cancer. And before grabbing its European cHL green light, Opdivo won the FDA’s blessing in head-and-neck cancer and posted positive phase 3 gastric cancer results.