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A biologics license application for sacituzumab govitecan has been granted a priority review by the FDA for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease, Immunomedics, the manufacturer of the antibody-drug conjugate, has announced.

Upfront ribociclib (Kisqali) has been granted approval by the FDA for use in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. Additionally, ribociclib was approved in combination with fulvestrant for postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer.

Overall survival was not improved with the combination of palbociclib and fulvestrant compared with fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, according to Pfizer, the developer of the CDK4/6 inhibitor.