FDA approves expanded indication for Ibrance

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib), based on the results from the confirmatory Phase III trial PALOMA-2, said the drug’s maker, US pharma giant Pfizer (NSYE: PFE), on Friday.

The FDA action converts the accelerated approval of Ibrance to regular approval and broadens the range of anti-hormonal therapy that may be administered with Ibrance. The drug is now indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole, as initial endocrine based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

Last month, the FDA approved Novartis’ (NOVN: VX) Kisqali as a first-line treatment for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. EP Vantage, the editorial arm of the Evaluate group, has estimated sales of Kisqali at $1.6 billion a year in 2022. Ibrance, which was approved early 2016, achieved sales of $723 million last year.