The Committee for Medicinal Products for Human Use recommended that the European Commission approve a dosing schedule of 480-mg infused over 60 minutes every four weeks as an option for patients with advanced melanoma and previously-treated renal cell carcinoma. The committee also backed a shorter dosing option of 240-mg infused over 30 minutes every two weeks for Opdivo’s six approved monotherapy indications in the 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,” Dr. Fouad Namouni, head of development for Bristol-Myers Squibb’s oncology business, said in prepared remarks.
The company’s PD-1 inhibitor works by blocking the mechanism that tumors use to hide from a patient’s immune system. Earlier this month, the FDA approved the four-week and 30-minute dosing options for patients in the U.S.
“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,” Namouni added.