Bristol-Myers Squibb Receives Positive European Agency Opinion

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of an every four-week (Q4W) 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 (Q2W) Opdivo dosing option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the EU. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

“BMS is committed to improving cancer care by, among other things, addressing scheduling and convenience concerns of patients with a range of dosing options for an Immuno-Oncology agent that allows for enhanced flexibility,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “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.”

(Source: Bristol-Myers Squibb Company)