SPPI - Spectrum rises 7% as FDA decides to review poziotinib for lung cancer subtype

The U.S. Food and Drug Administration (FDA) accepted for review Spectrum Pharmaceuticals' (NASDAQ:SPPI) new drug application (NDA) for poziotinib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The NDA was backed by positive data from a phase 2 study. The product has received Fast Track designation and the agency has expected to make a decision by Nov. 24, 2022. The company said that the FDA reiterated the importance of having the confirmatory trial substantially enrolled at the time of approval and requested additional information around dosing. The FDA also indicated that it is not currently planning to hold an advisory committee meeting for the application. SPPI +6.66% pre-market to $0.72

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Spectrum rises 7% as FDA decides to review poziotinib for lung cancer subtype