Spectrum says FDA did not grant BTD to poziotinib for treatment of NSCLC

Spectrum Pharmaceuticals, Inc. announced that based on a subset of data from MD Anderson’s ongoing Phase 2 study, the U.S. Food and Drug Administration did not grant Breakthrough Therapy Designation to poziotinib for the treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 20 mutations. The company’s overall development plan and timeline for a New Drug Application filing based on the first cohort of the ZENITH20 trial remains unchanged. Breakthrough Therapy Designation is one of several FDA programs designed to expedite the review of drugs to treat serious or life threatening conditions. Spectrum’s BTD application included data from 30 patients from the MD Anderson Phase 2 study who had failed platinum-based chemotherapy. The data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months. The safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.
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