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Thursday, September 22, 2022

FDA panel votes against Spectrum's lung cancer drug

 Advisers to the U.S Food and Drug Administration on Thursday voted against recommending Spectrum Pharmaceuticals' 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 and AstraZeneca's Enhertu.

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.

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