Pfizer has been boosted by the news that regulators in the USA have no plans to call a panel meeting to discuss its investigational breast cancer drug palbociclib.
The US Food and Drug Administration has informed the drugs giant that “at this time there is no plan for an Oncologic Drugs Advisory Committee meeting” for palbociclib, which will be marketed as Ibrance. Furthermore, Pfizer says it “continues to have an open and productive dialogue with the FDA” and has entered label discussions with the agency.
So all positive news for palbociclib which has a Prescription Drug User Fee Act goal date of April 13 after being assigned a priority review in October; it received FDA breakthrough therapy designation in April 2013. Pfizer is seeking approval for the drug based on the Phase II PALOMA trial which showed that a combination of palbociclib and the aromatase inhibitor letrozole doubled progression-free survival compared to letrozole alone.
Analysts believe that the lack of an FDA panel meeting, and the fact that label talks are taking place, suggest that the Phase II data may be enough to get palbociclib past the finishing post.
