FDA presenters said significant issues with the poziotinib application include its insufficient efficacy in the pivotal trial, the high rate of toxicity, inadequate dose optimization, and the delayed confirmation of benefit, as the company is yet to enroll patients in its proposed confirmatory study.
Futility analysis for the confirmatory trial is expected in 2024, with topline results in 2026.
Related Content: Spectrum Plunges After FDA Casts Doubts On Its Lung Cancer Candidate.
Poziotinib's marketing application is supported by data from a Phase 2 ZENITH20 trial, which showed that the tablets elicited an ORR of 28%, while the median duration of response (DOR) was 5.1 months.
"The ORR and DOR results observed in the primary efficacy population enrolled in ZENITH20 supporting this NDA may not provide a meaningful advantage over available therapies and may not be likely to predict clinical benefit," the FDA said in a briefing document.
Price Action: SPPI shares are down 16.48% at $0.53 during the premarket session on the last check Friday.
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