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Drug Review Profile Cancer Review Pathway

Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data

  • Analysis

Executive Summary

After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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