BRIEF—Ono and Bristol-Myers bid to bulk up Opdivo/Yervoy label in Japan

Opdivo (nivolumab) discoverer Ono Pharmaceutical and licensee Bristol-Myers Squibb have filed in Japan to add new information to the label for combination Opdivo/Yervoy (ipilimumab) in renal cell carcinoma.

The firms are seeking “a partial change in approved items of the manufacturing and marketing approval,” to include data from the Phase III CheckMate-214 study.

The study, which included patients in Japan, compared the combo therapy with Sutent (sunitinib) in patients with previously untreated advanced or metastatic RCC.

Meeting its co-primary endpoint, the study found the combination showed a significant improvement of overall survival in intermediate- and poor-risk patients.