FDA expands Pfizer’s Ibrance into HER2-positive breast cancer maintenance

25 June 2026

The US Food and Drug Administration (FDA) has approved US pharma giant Pfizer’s (NYSE: PFE) Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for adults with hormone receptor (HR)-positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy.

The decision gives Ibrance its first HER2-positive breast cancer indication and makes it the first CDK4/6 inhibitor approved for HR-positive metastatic breast cancer regardless of HER2 status, according to Pfizer.

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