FDA slams Spectrum and Oncopeptides cancer drugs over efficacy concerns ahead of ODAC meeting
The FDA’s Oncologic Drugs Advisory Committee meeting on Thursday will likely be a slaughter for two biopharma companies, Spectrum Pharmaceuticals and Oncopeptides, as reviewers today raised significant concerns and questions for both sponsors in briefing documents released ahead of the meeting.
Spectrum is seeking to win an approval for poziotinib tablets as a treatment for patients with previously treated, locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. Poziotinib’s NDA is supported by data from a Phase II ZENITH20 trial, which showed that the tablets elicited an ORR of 28% (95% CI, 18.9%-38.2%) in this patient population, while the median duration of response (DOR) was 5.1 months (95% CI, 4.2-5.5).
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