FDA Used Regulatory Loophole To Save Novartis' Farydak
FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.
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For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
Despite the agency’s preference that confirmatory trials generally be under way at the time of accelerated approval, Novartis’ panobinostat Phase III trial isn’t expected to begin for approximately three years.
Positive Phase III findings support Novartis’ plan for filing the pan-DAC inhibitor in 2014. The firm’s initial BLA for the compound, seeking accelerated approval in Hodgkin’s lymphoma, was rejected by FDA in 2011.