BMS’ Opdivo First EU Approved PD-1 Inhibitor

Bristol-Myers SquibbBristol-Myers Squibb’s (BMS’) Opdivo for the use in treatment for advanced skin cancer (unresectable or metastatic melanoma in adults) has been the first PD-1 inhibitor to gain approval by the European regulators. Last summer, the inhibitor became the first PD-1 inhibitor to be approved in the world when Japanese regulators approved it. In the US, the drug is cleared for both melanoma and metastatic squamous non-small cell lung cancer.

The approval has come from using data from two Phase III studies which showed the immunotherapy’s potential to boost response rates and overall survival versus standard care in both first-line and previously-treated settings. The results offered new hope to patients facing an average survival rate of just six months.

Comparison of Opdivo to the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma 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.  Furthermore, Opdivo has displayed 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.

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.

According to Dirk Schadendorf, director of the Clinic for Dermatology at University Hospital, Essen, 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”.


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