FDA approves palbociclib for male breast cancer

  • FDA

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • The US Food and Drug Administration (FDA) expressly added men to the indication for palbociclib, used in combination with endocrine therapy for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer.

Why this matters

  • This is 1 of the first FDA actions for male breast cancer.
  • Palbociclib is the first and only CDK 4/6 inhibitor indicated in combination with an aromatase inhibitor for the first-line treatment of men with HR+, HER2 advanced/metastatic breast cancer in the United States.

Key points

  • The FDA based its decision on a new analysis by Pfizer of postmarketing reports and electronic health records to show that the safety profile of palbociclib is consistent in men vs women.
  • No details of Pfizer's analysis were released by the FDA, but Pfizer said in its press release that findings would be presented at an upcoming medical meeting.
  • Breast cancer in males is rare, with only 2670 cases estimated in 2019 (
  • The majority of male breast cancers are HR+.
  • Because of its rarity, male breast cancer is more likely diagnosed at an older age and more advanced stage.
  • Male breast cancer is treated like that in females, according to current clinical practice guidelines.

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