Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL
In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.
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The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.
It has been more than two years since a sponsor went before the Oncologic Drugs Advisory Committee and won a favorable vote on approval of a new drug application. Can FDA really expect an advisory committee to keep saying ‘no’ all the time?