Europe Closer to Approving New Dosing Schedule for Opdivo

Europe Closer to Approving New Dosing Schedule for Opdivo

Following a similar decision in the United States earlier this month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new dosing schedule for Opdivo (nivolumab), the maker Bristol-Myers Squibb (BMS) announced.

The new dosing schedule allows physicians to choose to prescribe Opdivo as a 480 mg dose given every four weeks, or as a 240 mg dose administered every two weeks, in the treatment of advanced melanoma and previously treated renal cell carcinoma.

For the 480 mg regimen, infusion time is advised to be 60 minutes. For the 240 mg regimen, an infusion session is only 30 minutes. The CHMP recommendation will be reviewed by the European Commission.

“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,” Fouad Namouni, MD, head of development in oncology at BMS, said in a press release. “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 said.

The U.S. Food and Drug Administration (FDA) approved the new dosing schedule based on a study looking at Opdivo’s safety and effectiveness.

The findings of that study were presented at the American Association for Cancer Research Annual Meeting 2017, in a communication titled “A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types.

These findings showed that patients with melanoma, advanced non–small cell lung cancer (NSCLC), or advanced renal cell carcinoma who were treated with the 480 mg, four-week regimen, all shared similar predicted objective tumor responses when compared to patients who received the 240 mg, two-week dosing.

Patients also showed similar survival rates at one and two years.

The new 480 mg, four-week regimen is still being evaluated in two Phase 3 clinical trials, one for advanced melanoma (NCT02714218) and one for advanced or metastatic NSCLC (NCT02713867), which is currently recruiting up to 620 participants.