On February 11, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that its New Drug Application (NDA) for poziotinib has been accepted for review by the U.S. Food and Drug Administration (FDA) (Press release, Spectrum Pharmaceuticals, FEB 11, 2022, View Source [SID1234608026]).
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The NDA acceptance is based on the positive Phase 2 study results in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. There is currently no treatment specifically approved by the FDA for this indication. The product has received Fast Track designation and the agency has set a Prescription Drug User Fee Act (PDUFA) date of November 24, 2022. 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.
"The NDA acceptance is a major step toward advancing the treatment for patients with HER2 exon 20 insertion mutations in lung cancer," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "This remains an area of high unmet medical need as there are no treatments specifically approved for these patients. We are actively working with the agency to support the review process."
About the Phase 2 Study Results (Cohort 2 of ZENITH20 Study)
The Phase 2 study enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI), 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The median duration of response was 5.1 months and the median progression free survival was 5.5 months. In this cohort, 87% of patients had drug interruptions with 11 patients (12%) permanently discontinuing due to adverse events. 13 patients (14%) had treatment-related serious adverse events.