Bristol Myers Squibb has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) which recommended approval on Opdivo (nivolumab) for use as an adjuvant treatment in patients with completely resected stage IIB or IIC melanoma.
The therapy is intended for adults and adolescents aged 12 years and above.
This recommendation will be forwarded to the European Commission (EC), which will make a final decision.
CHMP’s positive opinion is based on results from the double-blind, randomised Phase III CheckMate -76K trial.
The trial compared the safety and efficacy of 480 mg Opdivo given every four weeks (Q4W) against placebo for 12 months.
Recurrence-free survival (RFS) is the primary endpoint while safety endpoints, progression-free survival on next-line therapy, distant metastases-free survival, and overall survival are secondary endpoints.
In comparison to the previous studies, the safety profile of Opdivo was found to be consistent.
During the follow-up of 7.8 months, Opdivo has shown to reduce the risk of recurrence or death by 58% against placebo.
Bristol Myers Squibb global programme lead vice-president Gina Fusaro said: “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.”
The company said, if approved, Opdivo will be the only PD-1 inhibitor indicated as an adjuvant treatment for patients within stages III, IV along with stages IIB, IIC resected melanoma.