FDA Approvals in Breast and Cervical Cancers

This week, the FDA approved new indications for two drugs. The first approval was for abemaciclib in combination 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 who are at high risk of disease recurrence and who also have a Ki67 score of 20% or higher. The next day, the agency approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1.

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