Nektar, Bristol-Myers Drug Combo Gets FDA Breakthrough Designation

By Colin Kellaher

Nektar Therapeutics (NKTR) and Bristol-Myers Squibb Co. (BMY) Thursday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to the combination of Nektar's bempegaldesleukin and Bristol's cancer drug Opdivo for patients with previously untreated unresectable or metastatic melanoma.

The companies said a phase 3 study evaluating the combination versus Opdivo alone in first-line advanced melanoma patients is currently recruiting patients.

Bempegaldesleukin, Nektar's lead immuno-oncology candidate, is designed to provide activation and proliferation of cancer-killing immune cells.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 01, 2019 07:44 ET (11:44 GMT)

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