FDA approves Bristol-Myers Squibb’s Opdivo for classical Hodgkin lymphoma

The approval is based on overall response rate in cHL patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.

Opdivo was assessed in two single-arm trials among patients with relapsed, refractory cHL.

In the study evaluating efficacy, treatment with Opdivo led to a 65% objective response rate and induced complete cancer remission in 7% of patients.

Severe adverse reactions like pneumonia or pleural effusion were reported in 21% of patients participating in the separate safety study.

Opdivo is cliamed to be the only immuno-oncology agent to secure eight approvals in less than two years in four different cancer types, including three solid tumors and now expanding to a hematologic malignancy.

Bristol-Myers Squibb US commercial head Chris Boerner said: "By expanding this Immuno-Oncology therapy into a hematologic malignancy, we continue to deliver upon our unwavering commitment to provide treatments that work directly with the body’s immune system for patients who are in need of new options.

"This is our second Immuno-Oncology agent in blood cancer in less than a year for patients impacted by diseases with a deep unmet need."

Last month, the FDA granted breakthrough therapy status for Opdivo to treat recurrent or metastatic head and neck cancer after platinum-based chemotherapy.