Breast Cancer

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Based on results from the phase III OlympiAD trial, the FDA approved olaparib (Lynparza), a PARP inhibitor, for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy. HR-positive patients must also have had prior endocrine therapy.

Some younger women with breast cancer may soon have a new first-line treatment option. Ribociclib (Kisqali), has been granted a breakthrough therapy designation by the FDA for use in combination with tamoxifen or an aromatase inhibitor (AI) as frontline treatment for pre- or perimenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

Trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which is co-developed by Mylan and Biocon, has just been approved by the FDA for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma, the same indications as trastuzumab.