European Medicines Agency recommends Opdivo for treatment of earlier melanoma stages

Key takeaways:

• Opdivo (nivolumab) is a programmed cell death protein 1 (PD-1) inhibitor.
• If approved, it will be the only PD-1 inhibitor indicated as adjuvant therapy for stage 2B through stage 4 of resected melanoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Opdivo for melanoma treatment in patients aged 12 years and older, according to a Bristol Myers Squibb press release.

The Committee for Medicinal Products for Human Use (CHMP) recommendation will now go before the European Commission for review.

“The CHMP’s recommendation brings us closer to potentially providing Opdivo for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the EU,” Gina Fusaro, PhD, vice president, global program lead of Bristol Myers Squibb, said in the release.

The recommendation suggests that Opdivo (nivolumab), a programmed cell death protein 1 (PD-1) inhibitor, be considered as a monotherapy for the adjuvant treatment of completely resected stage 2B or 2C melanoma. If approved, it would become the only PD-1 inhibitor indicated as adjuvant therapy for stages 2B, 2C, 3 and 4 of resected melanoma.

The positive opinion is based on results from the phase 3 CheckMate-76K trial in which patients treated with Opdivo experienced a reduction in the risk for recurrence or death by 58% compared with those treated with placebo after a minimum follow-up of 7.8 months (HR = 0.42; 95% CI, 0.3-0.59). Opdivo also maintained a safety profile that was consistent with previous trials.