NKTR-214 with Opdivo Earns FDA’s Breakthrough Therapy Designation for Advanced Melanoma

Source: Immuno-oncology, October 2019

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.

A global Phase 3 clinical trial (NCT03635983) comparing the effectiveness and safety of add-on NKTR-214 to Opdivo alone in first-line treatment of advanced melanoma patients is currently enrolling. More information on contacts, open locations and those yet to open can be found here.

NKTR-214, or bempegaldesleukin, is Nektar Therapeutics’ lead immuno-oncology candidate. It works by promoting the activation and proliferation of a subset of immune T-cells and natural killer (NK) cells, both capable of eliminating cancer cells.