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 […]
Archive | Regulatory
FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma
Posted in Melanoma News, Regulatory, Publications
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.
Posted in Melanoma News, Regulatory, Publications
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.
Posted in Melanoma News, Regulatory, Publications
Bempegaldesleukin Plus Nivolumab Granted Breakthrough Designation in Melanoma by the FDA
The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Posted in Melanoma News, Regulatory, Publications
