Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and expanded indications for older therapeutic agents used in breast cancer.
Abemaciclib Plus Endocrine Therapy
On March 3, 2023, the FDA expanded the indication for abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence. Abemaciclib was previously approved for high-risk patients with the additional requirement of having a Ki67 score ≥ 20%. The most recent approval removes the Ki67 testing requirement.
On February 3, 2023, the FDA approved sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic hormone receptor–positive, human HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
On January 27, 2023, the FDA approved elacestrant for postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. The FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant.