FDA Approves Eli Lilly’s Verzenio for Certain Types of Breast Cancer

FDA Approves Eli Lilly’s Verzenio for Certain Types of Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Verzenio (abemaciclib) for the treatment of HR-positive, HER2-negative type of advanced or metastatic breast cancer if a patient relapses after endocrine therapy. The FDA decision was delivered months ahead of its planned action date — the first quarter of 2018 — on the company’s new drug application (NDA), which the agency handled under Priority Review. The speedy review might have been linked to the fact that the FDA had earlier granted Verzenio a breakthrough therapy designation. Verzenio's approval in indicated to be used in combination with the endocrine therapy Faslodex (fulvestrant). But the approval also stated that patients can receive Verzenio as the sole treatment if they have failed endocrine therapy and chemotherapy given once the cancer metastasized. This set the therapy apart from other drugs acting in a similar manner. "Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy," Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a press release. The other drugs referred to by Pazdur — who is also the acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research — are Pfizer’s
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