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Keeping Track: US Approvals For Xpovio And Xembify Highlight Short Holiday Week

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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

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.

EU Accelerated Assessment – Hard To Get, Hard To Keep

It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.

US FDA, Advisory Committees Rarely Disagree

A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.

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