No breakthrough therapy designation for Spectrum's poziotinib

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) lost $4.05 (39%) to $6.39 on Dec. 20 after announcing after market close on Dec. 19 that based on data from an investigator-sponsored Phase II trial FDA did not grant breakthrough therapy designation to the company's poziotinib (HM781-36B) to treat metastatic non-small cell lung cancer (NSCLC) in patients with EGFR exon 20 mutations.

The company said it will continue to work with the agency to gain approval of poziotinib based on the Spectrum-sponsored pivotal Phase II ZENITH20 trial to treat NSCLC in patients with EGFR or HER2 exon 20 insertion mutations. Spectrum plans to submit an NDA to FDA based on data from a cohort of previously treated NSCLC patients in ZENITH20. Top-line data from that cohort are expected in 2H19...