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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.

The FDA approved abemaciclib (Verzenio) for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy. The CDK4/6 inhibitor has also been approved as a monotherapy for patients with HR+/HER2- breast cancer with metastatic disease who have previously received endocrine therapy and chemotherapy.