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FDA Rejects Spectrum’s Poziotinib NDA for NSCLC Treatment
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US-based Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) announced last week that its New Drug Application (NDA) for poziotinib, a treatment for previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations, received a complete response letter (CRL) from the US FDA. The CRL cited…
