FDA Approval Alert: The Need-to-Know | Capivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast Cancer

In November 2023, the FDA approved capivasertib plus fulvestrant for patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative with 1 or more PIK3CA, AKT1, or PTEN alterations, and has progressed on or after 1 endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant treatment.

Companion diagnostic designation for FoundationOne CDx may improve access to treatment with capivasertib plus fulvestrant among patients with hormone receptor–positive, HER2-negative breast cancer harboring select alterations.
FDA Approves FoundationOne CDx for Capivasertib Combo in Breast Cancer
Article
Nov 21, 2023 5:00 PM
Companion diagnostic designation for FoundationOne CDx may improve access to treatment with capivasertib plus fulvestrant among patients with hormone receptor–positive, HER2-negative breast cancer harboring select alterations.
Capivasertib Combo Is Best Suited to Pathway-Altered Advanced Breast Cancer
Capivasertib Combo Is Best Suited to Pathway-Altered Advanced Breast Cancer
Video
Nov 19, 2023 7:00 PM
Additional research is needed to confirm whether capivasertib/fulvestrant offers increased benefit in patients with locally advanced or metastatic breast cancer not harboring AKT pathway alterations.
Capivasertib Combo May Lead to QOL Improvement in Advanced HR+, HER- Breast Cancer
Capivasertib Combo May Lead to QOL Improvement in Advanced HR+, HER- Breast Cancer
Video
Nov 17, 2023 4:00 PM
Paolo Tarantino, MD, gives an overview on how the recently approved combination of capivasertib plus fulvestrant can help improve treatment strategies for patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative breast cancer
FDA Approves Capivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast Cancer
FDA Approves Capivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast Cancer
Article
Nov 16, 2023 10:58 PM
Patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative breast cancer with 1 or more PIK3CA, AKT1, or PTEN alterations may now receive capivasertib plus fulvestrant.