US FDA turns down Amgen lung cancer drug Lumakras for full approval (updated)

Mirati Therapeutics

26/12/2023 14:09

(Adds background in paragraphs 4-6)
       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.
    The FDA also issued a new post-marketing requirement for an
additional confirmatory study to support full approval that will
be completed no later than February 2028, Amgen said. 
        The company has said its older confirmatory study shows
that Lumakras reduced the risk of disease progression in
patients with advanced lung cancer by 34%, compared with
chemotherapy, but shows no significant difference in overall
survival.
  
        An 
    FDA advisory committee
     in October voted 10 to two that the main goal of that
late-stage study could not be relied upon to assess the benefits
of the drug. 
  
        Much of the committee's discussion centered on concerns
that trial investigators allowed too many patients to switch
between the treatment and control arms of the study.
  
        Lumakras is an oral drug designed to target a mutated
form of a gene known as KRAS that occurs in about 13% of
non-small cell lung cancers, the most common type of lung
cancer, and less frequently in some other solid tumors.
  

    

 (Reporting By Deena Beasley and Manas Mishra in Bengaluru;
Editing by Bill Berkrot and Anil D'Silva)
 ((deena.beasley@thomsonreuters.com; 213 955 6746; Reuters
Messaging: deena.beasley.thomsonreuters.com@reuters.net))