US approves Eli Lilly's Verzenio for certain advanced, metastatic breast cancers

The FDA announced Thursday that it approved Eli Lilly's Verzenio (abemaciclib) to treat certain adults with HR-positive, HER2-negative breast cancer. Specifically, the CDK4/6 inhibitor is cleared for use in combination with AstraZeneca's Faslodex (fulvestrant) after the cancer has advanced on endocrine therapy, and for use on its own if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasised. 

Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the agency's Center for Drug Evaluation and Research, remarked "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." 

The FDA noted that approval of Verzenio in combination with Faslodex was backed by safety and efficacy data from a randomised study involving 669 patients with HR-positive, HER2-negative breast cancer that progressed after treatment with endocrine therapy, but was not treated with chemotherapy following metastasis. In the placebo-controlled MONARCH 2 trial, the addition of Verzenio to Faslodex significantly prolonged progression-free survival by a median 16.4 months, versus 9.3 months for Faslodex alone. 

FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more. 

Meanwhile, approval of the drug as monotherapy was supported by data from the MONARCH 1 study of 132 patients with HR-positive, HER2-negative breast cancer that progressed after prior endocrine therapy and chemotherapy for metastatic disease. Results of the study showed that Verzenio monotherapy was associated with an overall response rate of 19.7 percent, with a median time to response of 3.7 months and a median duration of response of 8.6 months. 

The FDA granted priority review to Eli Lilly's submission of Verzenio in July. The drugmaker has also identified the drug as one of as many as 20 treatments that could reach the market by 2023. 

For related analysis, see ViewPoints: ESMO 2017 – A face in the crowd? Eli Lilly's abemaciclib seen to enhance class benefit of CDK4/6 inhibitors

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