FDA grants breakthrough designation to Opdivo for SCCHN

The FDA granted breakthrough therapy designation to nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who previously received platinum-based therapy.

The FDA based its decision on results of the phase 3 Checkmate -141 trial, an open-label, randomized trial that evaluated nivolumab (Opdivo, Bristol-Myers Squibb) in patients with recurrent or metastatic SCCHN whose tumors progressed within 6 months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting.

Researchers assigned patients to nivolumab or investigator’s choice of therapy. The trial met its primary endpoint of OS, and the study concluded in January.

“The breakthrough therapy designation for Opdivo in advanced SCCHN underscores the immediate need for new treatment approaches for this devastating disease, and reflects our commitment to advancing immuno-oncology research with the goal of addressing hard-to-treat cancers and changing survival expectations for patients,” Jean Viallet, MD, global clinical research lead of oncology at Bristol-Myers Squibb, said in a company-issued press release.

The FDA previously granted breakthrough therapy designation to nivolumab for four other indications: patients with Hodgkin lymphoma who failed autologous stem cell transplant and brentuximab vedotin (Adcetris, Seattle Genetics); those with previously treated advanced melanoma; patients with previously treated nonsquamous non–small cell lung cancer; and individuals with advanced or metastatic renal cell carcinoma.

Nivolumab is approved for single-agent treatment of patients with BRAF V600 wild-type and BRAF V600-positive unresectable or metastatic melanoma. It also is approved for treatment of patients with metastatic non–small cell lung cancer that progressed on or after platinum-based chemotherapy, as well as for the treatment of patients with advanced renal cell carcinoma who received prior antiangiogenic therapy.