The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
Regulatory
FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma
The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor response rate as treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade.1
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L
Polynoma LLC, announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L.
NKTR-214 with Opdivo Earns FDA’s Breakthrough Therapy Designation for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery.