FDA expands Opdivo use for metastatic melanoma

Source: Formulary Journal, February 2016

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.

Earlier this year, FDA approved Opdivo to treat patients with advanced squamous non-small cell lung cancer (NSCLC) and then, in early October, FDA expanded the use of Opdivo to also treat patients with non-squamous NSCLC. In late November, FDA also approved Opdivo for the treatment of patients with metastatic renal cell carcinoma.

Related: Opdivo approved for patients with metastatic renal cell carcinoma

“With this latest approval, both the Opdivo + Yervoy regimen, and Opdivo as a single-agent, are now available and represent important treatment options for patients with advanced melanoma, across BRAF status. For formulary decision-makers, this is particularly important as Opdivo now has seven approvals in just over a year,” said Greg Long, head of U.S. oncology payer marketing, Bristol-Myers Squibb. “With indications in 3 distinct tumor types, supported by extensive phase 3 trials at a consistent dose, Opdivo, as a single-agent and in combination with Yervoy, should be included on all managed care and hospital formularies to ensure it is readily available to patients in need.”