U.S. FDA panel votes against Spectrum's lung cancer drug (updated)

Spectrum Pharmaceuticals

22/09/2022 18:07

(Adds details on vote, background)
       Sept 22 (Reuters) - Advisers to the U.S Food and Drug
Administration on Thursday voted against recommending Spectrum
Pharmaceuticals'  SPPI.O  experimental drug for the treatment of
patients with a form of non-small cell lung cancer.
    The FDA panel voted 9 to 4 against the oral drug,
poziotinib, citing uncertainties around efficacy and side
effects.
        The decision of the panel was in-line with briefing
documents released by the FDA on Tuesday that raised concerns
over the efficacy of the treatment compared with existing drugs
like Daiichi Sankyo's  4568.T  and AstraZeneca's  AZN.L 
Enhertu.  urn:newsml:reuters.com:*:nL4N30R2ZW
    In the documents, the FDA said that given the concerns over
efficacy, toxicity, and significant delay in confirmation of
benefit, if the treatment is granted accelerated approval it
would be "the least effective targeted therapy for lung cancer
approved to date."
        The regulator is expected to make the final decision on
the  drug by Nov. 24. The FDA is not mandated to follow the
advise of its independent experts, but usually does. 
        Poziotinib is intended to treat non-small cell lung
cancer (NSCLC) with a rare genetic mutation that affects 2-4% of
total patients with NSCLC.
 (Reporting by Khushi Mandowara and Mrinalika Roy; Editing by
Shailesh Kuber)
 ((Khushi.Mandowara@thomsonreuters.com;))