Saturday, December 7, 2019

Saturday, December 7, 2019

Nektar Therapeutics, Bristol-Myers Squibb receive FDA breakthrough therapy designation


The U.S. Food and Drug Administration has granted breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) based on clinical data from the 2019 American Society of Clinical Oncology (ASCO) annual meeting. 

This would be for the treatment of previously untreated, unresectable or metastatic melanoma.  

"In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with the FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients," said Dr. Stephen Doberstein, senior vice president of research and development and chief R&D officer of Nektar Therapeutics. "Our teams are encouraged by the deepening of responses we observed in patients with previously untreated advanced melanoma who received the doublet therapy in our PIVOT-02 study. We look forward to continuing to provide updated results at a future medical meeting as the data mature further in this ongoing cohort of melanoma patients."

The breakthrough therapy designation will speed up the development and review of medicines, like bempegaldesleukin, which can potentially help people with life-threating diseases. Currently, a Phase 3 clinical trial evaluating bempegaldesleukin, Nektar’s lead immuno-oncology candidate, is recruiting patients. This clinical trial will evaluate bempegaldesleukin in combination with nivolumab versus nivolumab in first-line advanced melanoma patients.

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U.S. Food and Drug Administration (FDA)

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