Lilly Gets FDA Approval for Advanced Breast Cancer Treatment

Edward Kim  |

The National Cancer Institute at the National Institutes of Health estimates approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. Approximately 72% of patients with breast cancer have tumors that are HR-positive (hormone receptor) and HER2-negative (human epidermal growth factor receptor 2).

Eli Lilly (NYSE: LLY) received approval yesterday for a new therapy to treat patients with a common form of advanced or metastatic breast cancer. Lilly's product is called abemaciclib and will be branded as Verzenio. The FDA approved Verzenio to treat adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy. Verzenio is approved to be given in combination with fulvestrant, an endocrine therapy, and on its own, if patients were previously treated with endocrine therapy and chemotherapy after metastasis has occurred.

In many cancers, uncontrolled cell growth arises from a loss of cell cycle regulation due to increased signaling from kinases (enzymes that regulate cell function) called CDK4 and CDK6, cyclin-dependent kinases that are associated with the cycle of cell division. Verzenio is an oral cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting these kinases.


Source: Mosmedpreparaty

"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, MD, 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. Lilly had received the FDA's Breakthrough Therapy designation in 2015 for abemaciclib and Priority Review status in July 2017.

The median progression-free survival for patients taking Verzenio with fulvestrant was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant. Further, 19.7% of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median 8.6 months, according to the FDA's press release.

According to the Associated Press, Verzenio will cost $10,948 per month, and Lilly is offering patients financial assistance, including 12 months with a minimal copayment for those with commercial insurance. Verzenio will compete with two drugs in the same class, Ibrance (Pfizer) and Kisqali (Novartis). "Both cost about the same amount but can't be given as stand-alone treatments to those patients."

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