US FDA issues safety warning on three breast cancer drug

16 September 2019
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On Friday, the US Food and Drug Administration issued a safety warning on three already-marketed drugs used to treat some patients with advanced breast cancers, saying they may cause rare but severe inflammation of the lungs.

The drugs involved are: Pfizer’s (NYSE: PFE) Ibrance (palbociclib), Novartis’ (NOVN: VX) Kisqali (ribociclib), and Eli Lilly’s (NYSE: LLY) Verzenio (abemaciclib).

The FDA said: “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 benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.”

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