MedPage Today November 16, 2023
— No easy answers for two drugs for rare lymphoma on long cruise with accelerated approval
An unprecedented wait for final FDA approval will drag on for two orphan lymphoma drugs, at least a little while longer, as the agency decides how to end the delays and prevent them from happening again.
The dihydrofolate reductase inhibitor pralatrexate (Folotyn) received accelerated approval in 2009 and the histone deacetylase (HDAC) inhibitor belinostat (Beleodaq) in 2014, both for adults with relapsed/refractory peripheral T-cell lymphoma (PTCL). As is often the practice for accelerated approval, both drugs received conditional approval on the basis of small single-arm trials with a primary endpoint of objective response rate (ORR), which was 26-27% in both studies. Final approval was...
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