FDA expands approved use of Bristol-Myers Squibb’s late-stage melanoma treatment
“For nearly a decade, our researchers have worked tirelessly to find treatment options that could improve outcomes for patients with late-stage melanoma, a particularly aggressive cancer, and we are incredibly proud of today’s approval to expand the use of the Opdivo + Yervoy Regimen to include patients with BRAF mutation-positive unresectable or metastatic melanoma,” Bristol-Myers Squibb Head of U.S. Commercial Chris Boerner said.
The FDA approval is accelerated and comes as a result of progression-free survival (PFS) data garnered from the Phase III CheckMate-067 trial. The approval may be subject to confirmatory trials.
“Patients with metastatic melanoma historically have a very challenging disease,” Dr. Jedd Wolchok, chief of melanoma and immunotherapeutics service at Memorial Sloan Kettering Cancer Center, said. “Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope … 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.”