- 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.
- 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.
Prescribing information, click here.