The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of classical Hodgkin’s lymphoma (cHL) in patients who relapsed or progressed after receiving an autologous stem cell transplant (ASCT) and Adectris (brentuximab vedotin) treatment.
In May, the U.S. Food and Drug Administration (FDA) approved Opdivo, a PD-1 inhibitor, for the same indication.
Bristol-Myers Squibb said the European Commission (EC) will now review CHMP’s opinion, with a final decision on marketing authorization for Opdivo expected later this year.
“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,” Emmanuel Blin, senior vice president and chief strategy officer of Bristol-Myers Squibb, said in a recent press release.
“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,” he added.
CHMP’s positive opinion on Opvido was based on data from two single-arm, multicenter trials that evaluated the safety and effectiveness of the drug in patients with Hodgkin’s lymphoma who had failed to respond or relapsed following HSCT and Adcetris treatment, regardless of PD-L1 expression: the ongoing Phase 2 CheckMate-205 (NCT02181738) and the Phase 1 CheckMate-039 (NCT01592370).
In the trials, patients were treated with Opdivo intravenously every two weeks until disease progression, death, unacceptable toxicity, or trial withdrawal. Patients in both studies had undergone a median of five prior systemic regimens and received a median of 17 doses of Opdivo over 8.3 months.
The combined data showed that Opdivo delivered an objective response rate of 66 percent. The drug’s safety was also assessed in a combined analysis of both trials involving 263 adult cHL patients. Twenty-one percent of these patients had serious treatment-related adverse reactions, with the most frequent adverse events (reported in at least 20 percent of patients) being infusion-related reactions, pneumonia, abnormal collection of fluid in the pleural space, fever, rash, and pneumonitis.
“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,” Blin said.