Bristol-Myers receives positive CHMP opinion for Opdivo
Bristol-Myers Squibb announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The CHMP positive opinion is based on data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials, evaluating patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin. These results showed Opdivo delivered an objective response rate, as assessed by an independent radiologic review committee, of 66%. In CheckMate -205 and -039, among all patients (safety population: n=263), the most common adverse events (reported in at least 20%) were fatigue (32.3%), diarrhea (28.9%), pyrexia (27.1%) and cough (25.9%).