FDA expands approval of Opdivo plus Yervoy for melanoma

Source: Healio.com/hematology-oncology, January2016

The FDA expanded the approval of nivolumab plus ipilimumab to include all patients with unresectable or metastatic melanoma, regardless of BRAF V600 mutational status.

Until now, the combination only had been indicated for patients with BRAF V600 wild-type disease.

Nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) is the only FDA-approved combination of immune checkpoint inhibitors.

“Patients with metastatic melanoma historically have a very challenging disease,” Jedd D. Wolchok, MD, PhD, chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center and a HemOnc Today Editorial Board member, said in a press release. “Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope.

“The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” Wolchok added. “This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an immuno-oncology combination treatment, and the potential for improved outcomes.”