Lilly’s Advanced HR+ Breast Cancer Drug Gains FDA Approval
Eli Lilly’s Verzenio (abemaciclib) has now been approved by the Food and Drug Administration for women and men with what’s called HR-positive, HER2-negative breast cancer that has worsened after hormone therapy.
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.
“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, M.D., 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.
The drug, abemaciclib, which will be sold under the brand name Verzenio, will carry a list price before any discounts or rebates of about $10,948 per month, Lilly said.
Verzenio belongs to a newer class of oral medicines called CDK 4/6 inhibitors that
block cancer cells’ ability to divide and proliferate.The safety and efficacy of Verzenio in combination with fulvestrant were studied in a randomized trial of 669 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized. The study measured the length of time tumors did not grow after treatment (progression-free survival). 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.
Verzenio, like all cancer therapies, may cause severe side effects. The studies demonstrated that Verzenio can cause severe diarrhea, a depletion of certain immune cells, abnormal liver blood tests, and blood clots. Moreover, it may be toxic to developing fetuses. Other common side effects include nausea, depletion of various types of blood cells, infections, and vomiting.
An estimated 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease, according to the National Institutes of Health. About 72 percent of patients with breast cancer have tumors that are HR-positive and HER2-negative.
