Biopharmaceutical company Spectrum Pharmaceuticals Inc (NasdaqGS:SPPI) revealed on Friday that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) 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) harbouring HER2 exon 20 insertion mutations.
In the letter, the FDA indicated that the poziotinib application cannot be approved in its present form. Based on the CRL, Spectrum would have to generate additional data including a randomised controlled study prior to approval.
"While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed," commented Tom Riga, president and CEO of Spectrum Pharmaceuticals. "After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritise the poziotinib programme."
Riga added that the company continues 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" and will explore potential strategic alternatives for the drug.
Spectrum will focus efforts on driving growth for its recently launched commercial drug, Rolvedon, which was approved by the FDA in September 2022 for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
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