FDA approves Eli Lilly’s Verzenio for metastatic breast cancer treatment

Eli Lilly and Company (Lilly) has announced receiving U.S. Food and Drug Administration (FDA) approval for Verzenio (abemaciclib), to treat patients with metastatic breast cancer who have seen progression after previous treatment. This recent approval allows for the use of Verzenio in combination with fulvestrant in patients whose cancer has advanced on endocrine therapy.

Detailed Insights on Verzenio’s Approval and Application

The approval focuses on patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. These patients have previously undergone therapy that alters their hormone levels (endocrine therapy) and have experienced progression of their disease. Verzenio can also be administered as a standalone treatment for those who have previously been treated with both endocrine therapy and chemotherapy after their cancer progressed.

Comments from FDA’s Oncology Center of Excellence

Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, highlighted the significance of this approval. “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 Pazdur.

Clinical Trial Success and Mechanism of Action

Verzenio works by inhibiting cyclin-dependent kinases 4 and 6, enzymes that are known to promote the growth of cancer cells. The approval follows successful results from the MONARCH 2 phase 3 trial, where Verzenio, in combination with fulvestrant endocrine therapy, significantly improved progression-free survival among patients.

Future Prospects and Launch Plans

Following this approval, Lilly is preparing to launch Verzenio in the U.S. market in October. This move is expected to provide a substantial new treatment option for patients battling this challenging form of cancer.

This FDA approval marks a crucial development in the treatment of metastatic breast cancer, particularly for patients who have limited responses to conventional therapies. Verzenio’s ability to be used both in combination with other treatments and as a standalone option offers flexibility and hope for patients seeking effective solutions for advanced cancer stages.