Posted by Michael Wonder on 01 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb announce U.S. FDA breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Opdivo (nivolumab) for the treatment of patients with untreated advanced melanoma
1 August 2019 - Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The breakthrough therapy designation is based on clinical data which were recently reported at the 2019 American Society of Clinical Oncology Annual Meeting from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase 1/2 clinical study.
