2022-11-25 11:00:00

Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poz

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Benzinga
By Business Wire

Immediately de-prioritizes poziotinib program, accelerates cost reductions, including 75% reduction in R&D related workforce

Spectrum to explore strategic alternatives for the poziotinib program, including partnerships and business development opportunities

Spectrum Pharmaceuticals, Inc. SPPI (Spectrum or the Company), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum's New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.

While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program, said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed.

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