publication date: Sep. 29, 2017

Drugs and Targets FDA approves Verzenio for advanced or metastatic breast cancers

FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones.

Verzenio, sponsored by Eli Lilly, is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread.

“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,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Verzenio works by blocking certain molecules (known as cyclin-dependent kinases 4 and 6), involved in promoting the growth of cancer cells. There are two other drugs in this class that are approved for certain patients with breast cancer, palbociclib approved in February 2015 and ribociclib approved in March 2017.

The safety and efficacy of Verzenio … Continue reading FDA approves Verzenio for advanced or metastatic breast cancers

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