Spectrum’s Delay In Starting Confirmatory Trial Of Poziotinib Troubles US FDA
Ahead of advisory committee review, agency cites poziotinib’s marginal anti-tumor activity, high rates of toxicity, and lack of dose optimization. Company seeks accelerated approval but was given standard review.
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Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.
Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’