EMA validates Bristol-Myers Squibb’s application for expanded use of Opdivo cancer drug

Opdivo is currently approved to treat various types of melanoma, lung cancer and kidney cancer.

The data supporting the type II variation application was generated in the phase 2 CheckMate-205 trial, under which Opdivo was assessed in cHL patients who have received autologous stem cell transplant and brentuximab vedotin.

The full results of the study are anticipated to be presented at a medical meeting later this year.

The application’s validation confirms the submission is complete and starts the EMA’s review process.

Bristol-Myers Squibb oncology global clinical research lead Jean Viallet said: "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."

Earlier this year, the US Food and Drug Administration (FDA) has once again expanded the indications for Opdivo.

Bristol-Myers Squibb is now allowed to use Opdivo in combination with Yervoy (ipilimumab) to treat unresectable or metastatic melanoma across BRAF mutational status.

Last November, the FDA also approved Opdivo to treat patients with advanced renal cell carcinoma, who have received prior anti-angiogenic therapy.