U.S. FDA staff raises concerns on Spectrum Pharma's cancer drug (updated)

Spectrum Pharmaceuticals

20/09/2022 15:20

(Adds details from the briefing document)
    Sept 20 (Reuters) - The U.S. Food and Drug Administration's
(FDA) staff on Tuesday raised concerns over the safety of
Spectrum Pharmaceutical's  SPPI.O  experimental cancer drug and
questioned the benefits it provided over existing therapies,
dragging its shares 30%.
    The concerns over poziotinib were raised in the regulator's
briefing documents ahead of a meeting of its external advisers
on Thursday.
    The reviewers cited lack of clarity on whether poziotinib
provided enough duration of response in treating a type of
non-small cell lung cancer, compared with existing drugs like
Daiichi Sankyo's  4568.T  and AstraZeneca's  AZN.L  Enhertu.
    "If granted accelerated approval, this would be the least
effective targeted therapy for lung cancer approved to date,"
the briefing documents said, citing the 28% overall response
rate and duration of 5.1 months for the therapy.
    FDA's questions on the toxicity profile of the drug was due
to 85% of patients on the 16 mg once daily dosage experiencing
serious adverse effects, while 57% patients experienced dose
reductions.
    Side effects may reduce if patients receive alternative
dosages, but it remains unclear whether efficacy can be
maintained based on data submitted to FDA, the documents said. 

 (Reporting by Leroy Leo and Khushi Mandowara in Bengaluru;
editing by Uttaresh.V)
 ((Leroy.Dsouza@thomsonreuters.com ; Twitter: https://twitter.com/LeroyLeo7;))