Spectrum Pharmaceuticals Lawsuit Submission Form

According to the filed complaint, defendants were conducting a phase 2 clinical trial called ZENITH20, which was an ongoing, multicenter, multi-cohort, open-label, activity-estimating study evaluating the anti-tumor effects, safety, and tolerability of poziotinib in patients with locally advanced or metastatic non-small cell lung cancer that have certain mutations and were previously treated with the standard of care. Although defendants represented that the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated a required confirmatory phase 3 study, on September 20, 2022, a briefing document from the United States Food and Drug Administration Oncologic Drugs Advisory Committee disclosed not only negative data on the safety and efficacy of poziotinib, but also a failure by the Company to enroll any patients in a required phase 3 confirmatory trial.