The U.S. Food and Drug Administration has approved a drug developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) for the treatment of advanced or metastatic breast cancer. The approval comes less than three months after Verzenio was submitted to the FDA for review.
The FDA it has approved Verzenio, also known as abemaciclib, in combination with an endocrine therapy known as fulvestrant. It is also approved on its own if patients who previously received 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.
In July, Lilly submitted a New Drug Application for Verzenio which received a Priority Review designation, meaning the FDA had up to eight months to give approval or rejection instead of the usual 12 months.
"The FDA approval of this new treatment is an important milestone for people with advanced breast cancer as there is a pressing need for new medicines that address the significant treatment challenges these patients face," said Levi Garraway, senior vice president, product development and medical affairs for Lilly Oncology. "(The) announcement further underscores Lilly’s commitment to help people with cancer live longer, healthier, more active lives."
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