Opdivo first PD-1 inhibitor given European approval for haematological cancer

pharmafile | November 25, 2016 | News story | Medical Communications, Sales and Marketing |  BMS, Bristol-Myers Squibb, EMA, PD1-Inhibitor, bristol myers-squibb 

Bristol-Myers Squibb announced that it has received the first and only European approval for a PD1 inhibitor in the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL). The approval gives Opdivo a boost in its battle with rival Merck’s Keytruda.

The EMA has cleared Opdivo for the treatment of adults with cHL who have previously received an autologous stem cell transplant and treatment with brentuximab vedotin. The approval was based on data from a Phase 2 trial, Checkmate-205, and a Phase 1 trial, Checkmate-039. The two studies displayed a 66% response to the drug and certain patients, 6%, had a complete response to the drug.

The approval widens Opdivo’s indication and provides them with a lead on Merck’s Keytruda, in terms of reach. BMS are pushing to widen Opdivo’s use, with the drug currently approved in over 57 countries and 25,000 patients enrolled to date in the Opdivo clinical development program. Opdivo necessarily needs to make up this ground as Keytruda had recently been approved for first line treatment for non-small-cell lung cancer. This indication is one that Opdivo crucially missed, after posting results that displayed that it fared worse as a first line treatment when compared against standard treatment.

Emmanuel Blin, senior vice president and chief strategy officer, BMS, commented, “We’re incredibly proud of this approval for Opdivo and what it means for adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin, as it marks the first and only PD-1 inhibitor approved for a hematologic malignancy in the EU. This also is Bristol-Myers Squibb’s second Immuno-Oncology agent approved for a blood cancer in the EU within just six months.”

Ben Hargreaves