US FDA turns down Amgen lung cancer drug Lumakras for full approval
26/12/2023 14:03
Dec 26 (Reuters) - The U.S. Food and Drug Administration
on Tuesday declined to grant traditional approval to Amgen's
AMGN.O Lumakras for treating lung cancer patients with a
specific gene mutation, but did not withdraw the drug's existing
accelerated approval status.
Lumakras was approved by the FDA in 2021 under an
accelerated pathway, with confirmatory data a condition for
gaining traditional approval.
(Reporting By Deena Beasley and Manas Mishra in Bengaluru;
Editing by Bill Berkrot)
((deena.beasley@thomsonreuters.com; 213 955 6746; Reuters
Messaging: deena.beasley.thomsonreuters.com@reuters.net))
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