European regulators have issued a green light for Bristol-Myers Squibb’s Opdivo as a treatment for advanced skin cancer, making it the first PD-1 inhibitor to win approval in the region.

After an accelerated assessment Opdivo (nivolumab) has now been cleared by the European Commission for use in all 28 member states to treat unresectable or metastatic melanoma in adults, regardless of BRAF status.

The approval comes on the back of data from two Phase III studies (CheckMate -066, -037) showing the immunotherapy’s potential to boost response rates and overall survival versus standard care in both first-line and previously-treated settings, offering new hope to a group of patients facing an average survival rate of just six months.

CheckMate-066 compared Opdivo to the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma and showed an objective response rate of 40% versus 14% and a one-year survival rate of 73% vs 42%, respectively, as well as a 58% reduction in the risk of death. 

As an added bonus, Opdivo’s safety profile also seemed to hold up well, with fewer discontinuations (6.8% vs 11.7%) and treatment-related Grade 3/4 adverse events (11.7% vs 17.6%) observed in the DTIC group, the firm noted.

A step forward

According to Dirk Schadendorf, director of the Clinic for Dermatology at University Hospital, Essen, Germany, Opdivo’s approval is “an important step forward in offering a new option for advanced melanoma patients in the European Union, especially considering that long-term benefits have largely been elusive in this treatment category”.

In July last year, the closely-watched checkpoint inhibitor became the first PD-1 inhibitor to be approved in the world when Japanese regulators OK’d its use for unresectable melanoma. In the US, the drug is cleared for both melanoma and metastatic squamous non-small cell lung cancer, for which it has also recently received backing from European regulatory advisors. 

BMS’ drug could soon face competition from MSD’s rival PD-1 inhibitor Keytruda (pembrolizumab), which also won the Committee for Medicinal Products for Human Use’s favour last month as an option for treating advanced skin cancer.