Nektar, Bristol-Myers Drug Combo Gets FDA Breakthrough Designation
01 August 2019 - 9:59PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2024 to May 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From May 2023 to May 2024