Over 10 years later, FDA officially pulls a BMS accelerated approval, and a Teva copycat falls with it
While formally announcing the withdrawal of the peripheral T-cell lymphoma (PTCL) indication for Bristol Myers Squibb’s Istodax (romidepsin) for injection (the company made a similar announcement last summer) on Friday, the agency also said it’s pulling Teva’s 505(b)(2) application, after the cancer drug failed its confirmatory trial.
The final announcement on the withdrawal comes more than ten years after the FDA initially granted an accelerated approval for Istodax in PTCL in 2011, revealing again just how long it can take the agency to finalize such a withdrawal, even when confirmatory results show failure. The House Energy & Commerce committee recently introduced a measure that would shore up that accelerated approval withdrawal process, but companies will still be able to take requests for withdrawals before adcomms.
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