Bristol-Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II variation application of Opdivo (nivolumab), which seeks to extend Opdivo’s current indications to include the treatment of classical Hodgkin’s lymphoma (cHL) patients after prior therapies.
The validation confirms that the application is complete, and the EMA will now begin a centralized review process before reaching a decision on the expanded indication request.
Data from the CheckMate-205 clinical trial, a Phase 2 study evaluating the safety and efficacy of Opdivo in patients with relapsed or refractory (r/r) cHL, was included in the application. The study, “Study of Nivolumab in Subjects With Classical Hodgkin’s Lymphoma (Registrational) (CheckMate 205),” evaluated Opdivo in cHL patients who had received an autologous stem cell transplant and brentuximab vedotin. Results are expected to be presented at a medical meeting this year.
“We are eager to continue to extend the use of Opdivo as a treatment option and potentially provide hematology with its first PD-1 inhibitor, a type of treatment that is designed to work with the PD-1 pathway and leverage the immune system to help fight classical Hodgkin lymphoma,” Jean Viallet, MD, Bristol-Myers Squibb’s Oncology Global Research Lead, Jean Viallet, M.D., said in a press release. “We are hopeful to build on expanding our hematology franchise and bring the science of Immuno-Oncology to these adult relapsed and refractory classical Hodgkin lymphoma patients in Europe who often have limited remaining treatment options.”
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval in July 2014 in Japan, and now has regulatory approval in 48 countries including the U.S., European Union, and Japan. Among other indications, it used as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma, and BRAF V600 mutation-positive unresectable or metastatic melanoma, and in patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy.
The inhibitor binds to the checkpoint receptor PD-1, expressed on activated T-cells, allowing them to recognize tumors (cancer cells can exploit checkpoint pathways to shield tumors from immune system attacks). Opdivo works by blocking the binding of PD-L1 and PD-L2, and preventing PD-1 pathway’s suppressive signaling on the immune system.