The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...

In a move that may become more common as the US Food and Drug Administration’s (FDA) comfort with real-world data (RWD) increases, FDA on Thursday approved a new indication for Pfizer’s Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with certain types of metastatic breast cancer. The approval is based on RWD from electronic health records and postmarketing reports of Ibrance in male patients sourced from three databases: I...

The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs). The list targets what trials should be run by those developing a number of new generic oncology treatments, though many have yet to lose patent protection and some were recently approved, including Pfizer’s breast cancer drug Ibra...