https://www.myelomabeacon.com/news/2015/02/23/farydak-panobinostat-fda-approval/
An Eventful Road To Approval
The FDA’s decision to approve Farydak is likely to come as a surprise to many people. The drug was reviewed during an FDA advisory committee meeting in early November last year, but failed to gain the support of the committee, which voted 5 to 2 against recommending the drug for FDA approval (see related Beaconnews).
The FDA typically makes approval decisions that reflect the recommendations of its advisory committees. Thus, there was widespread pessimism about Farydak’s chances for FDA approval following the early November advisory committee vote.
Some of that pessimism dissipated, however, when the FDA announced late in November that it was giving itself an extra three months to reach a decision on Farydak’s approval application. Had it not taken that step, the agency would have had to announce its decision by the end of November (see related Beacon news).
There are many reasons why the FDA can decide to delay an approval decision. However, in this case, one reasonable interpretation was that the agency was unwilling to make a quick decision based on its advisory committee’s recommendation.
There also was speculation at the time that one option the FDA might be considering was an approval of Farydak that was more restrictive than what Novartis requested in its approval application.
This, in fact, is what has happened.