Bristol-Myers Squibb Company has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval ofOpdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) 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.
“We recognize the enormous challenges facing classical Hodgkin lymphoma patients who do not respond to or who progress following currently available treatments, and we are dedicated to helping these patients in their fight against this devastating disease,” said Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb. “Today’s CHMP positive opinion marks an important milestone in applying our Immuno-Oncology science to delivering a treatment option for patients with this hematologic malignancy. If approved by the European Commission, Opdivo will become the first PD-1 inhibitor approved to treat a hematologic malignancy in the European Union, further building on our established heritage in blood cancer care.”
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%).