SPPI - Spectrum Pharma fails to win FDA AdCom backing for cancer therapy

• An independent group of experts voted against the approval of lung cancer drug poziotinib developed by clinical-stage biotech Spectrum Pharmaceuticals ( NASDAQ: SPPI ) on Thursday, clouding its path for FDA approval.
• With a PDUFA date on Nov. 24, the tyrosine kinase inhibitor is currently under FDA review as a treatment for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations.
• On the question of whether its benefits outweighed the risks, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 – 4 to reject the therapy.
• The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
• Currently, SPPI shares are on hold for trading.
• The stock plunged ~37% Tuesday when the FDA published briefing documents which, according to H.C. Wainwright, suggested a more “argumentative” AdCom meeting.

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