CHMP recommends approval of Bristol-Myers Squibb’s Opdivo

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Opdivo from Bristol-Myers Squibb Co. be approved to treat relapsed or refractory classical Hodgkin lymphoma (cHL) in adult patients who have previously received autologous stem cell transplant (ASCT) and been treated with brentuximab vedotin.
“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,” Bristol-Myers Squibb Senior Vice President and Chief Strategy Officer Emmanuel Blin said. “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 next step in the approval process will be for the approval recommendation by CHMP to be reviewed by the European Commission, which has been given authority by the European Union to approve medications.