Opdivo snags two new cancer approvals

May 18, 2016

Nivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.

Nivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.

FDA  approved Opdivo for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. Plus, the drug received Breakthrough Therapy Designation to treat recurrent or metastatic squamous cell carcinoma of the head and neck

Related: FDA expands Opdivo use for metastatic melanoma

The squamous cell carcinoma indication is the fifth Breakthrough Therapy Designation granted the drug. Previous indications include patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and advanced or metastatic renal cell carcinoma.

The FDA based its decision on the results of a Phase 3, open-label, randomized trial (CheckMate-141), which evaluated Opdivo versus investigator’s choice of therapy in patients with recurrent or metastatic SCCHN. Patients in the study had experienced tumor progression within six months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting.

The study was stopped early in January, 2016, after an assessment conducted by the independent Data Monitoring Committee determined that the study met its primary endpoint of overall survival. 

Related: Opdivo approved for patients with metastatic renal cell carcinoma

FDA’s approval of Opdivo for cHL is the first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin. It is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials.

 

Opdivo delivered a high response rate, with an objective response rate (ORR) of 65%. The percentage of patients with a complete response was 7%, and the percentage of patients with a partial response was 58%. Plus, among patients who responded, the duration of response was maintained over time for a median of 8.7 months.

Read more: FDA approves additional indication for Opdivo