Poziotinib’s Shift Of Focus To HER2 May Increase Approval Chances
Potential First-Line Therapy
Encouraging new data for Spectrum/Hanmi’s poziotinib presented at ESMO may increase the chances of approval for the pan-HER inhibitor as a possible first-line therapy for NSCLC with the HER2 exon 20 insertion mutation, although the patient population is limited.
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Spectrum is set to discuss NDA submission plans with the US FDA after unveiling positive top line results from Cohort 2 of the Phase II ZENITH20 study with poziotinib, in pretreated NSCLC patients with HER2 exon 20 insertion mutations. The drug, licensed from Hanmi, failed in the Cohort 1 part of the trial earlier this year.
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