SPPI - FDA grants fast track status to Spectrum Pharmaceuticals' poziotinib

Spectrum Pharmaceuticals (SPPI) announces that the U.S. FDA has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer ((NSCLC)) in previously treated patients with HER2 exon 20 mutations.Shares of the company jump nearly 26% premarket.Spectrum plans to submit a new drug application ((NDA)) for poziotinib later this year.Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions and fill unmet medical needs, with the intention of getting important new drugs to patients earlier.There are currently no approved therapies to treat patients with HER2 exon 20 mutations.

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FDA grants fast track status to Spectrum Pharmaceuticals’ poziotinib