Cobimetinib (trade name: Cotellic) has been approved since November 2015 in combination with vemurafenib for the treatment of adults with advanced, i.e. metastatic or unresectable, melanoma with a BRAF V600 mutation. The Federal Joint Committee (G-BA) therefore commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to examine whether cobimetinib in combination with vemurafenib has an added benefit over the appropriate comparator therapy vemurafenib alone.
Regulatory
Drug combination shows benefit for men with melanoma
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.
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.