Bristol-Myers Reports Positive CHMP Opinion For Opdivo - Quick Facts

(RTTNews) - Bristol-Myers Squibb Company (BMY) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of an every four-week Opdivo (nivolumab) dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma. The CHMP also recommended approval of a two-week Opdivo dosing option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the EU.

Fouad Namouni, head of development, Oncology, Bristol-Myers, said: "This positive CHMP opinion reinforces our commitment and we look forward to hearing from the European Commission. Once approved, the Opdivo four-week dosing infused over 60 minutes would enable BMS to deliver on our promise to explore potentially more flexible and convenient dosing options for patients, caregivers and healthcare providers alike."