A drug combination approved last year by the U.S. Food and Drug Administration may have a greater effect for men with melanoma than previously reported, according to a new analysis of clinical trial data.
Regulatory
Expert Shares Challenges, Considerations When Using Immunotherapies in Melanoma
The field of melanoma recently gained an influx of immunotherapy approvals, and advancement in the field doesn’t seem to be slowing down.
When the FDA expanded the drug’s label in December 2015, pembrolizumab (Keytruda) became the first anti–PD-1 therapy approved for previously untreated patients with advanced melanoma, regardless of BRAF status.
Nivolumab’s Growing Role in the Melanoma Treatment Paradigm –
In early February, the FDA granted expanded approval to nivolumab (Opdivo) as both a single agent, as well as in combination with ipilimumab (Yervoy), for patients with melanoma exhibiting BRAF V600 mutations. This expansion puts nivolumab in the frontline for all patients with advanced melanoma, which Jedd D. Wolchok, MD, PhD, says will be beneficial for patients.
FDA expands Opdivo use for metastatic melanoma
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.