BMS Nabs Expanded Indications for Hep C Drug in Europe

Bristol-Myers Squibb has scored a big win in Europe with Daklinza, with regulators blessing expanded use of the hepatitis C drug in three new patient populations.

As a result of the decision, Daklinza can be used in combination with Gilead Sciences’ Sovaldi in patients with chronic HCV who also have decompensated cirrhosis, HIV-1 coinfection or post-liver transplant recurrence of HCV.

In same-day news, BMS reported that it had stopped a Phase 3 Opdivo study in head and neck cancer early because it met the primary endpoint, demonstrating superior overall survival in patients on the study drug.

Opdivo was the first PD-1 immune checkpoint inhibitor to be approved globally. The CheckMate -141 trial evaluated Opdivo in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck against standard of care therapy. Secondary endpoints included objective response rate and progression-free survival.