FDA clears Eli Lilly’s Verzenio for treatment of early breast cancer

USA – The Food and Drug Administration (FDA) has given a positive nod to abemaciclib (Verzenio) in combination with endocrine therapy for adjuvant treatment of certain patients with early breast cancer.

The approval applies to use of the agent by adults with hormone receptor-positive, HER2-negative, node-positive disease at high risk for recurrence who have a Ki-67 score of at least 20% as determined by an FDA-approved test.

The FDA noted in announcing the approval that the oral Cyclin Dependent Kinase 4/6 (CDK 4/6) inhibitor is the first to be approved for adjuvant treatment of breast cancer.

Breast cancer is the most common type of cancer in women, with more than 276,000 new cases estimated in 2020. CDK4/6 inhibitors are designed to interrupt the growth of cancer cells.

The FDA granted approval based on the results of the monarchE trial, which included adult women and men with hormone receptor-positive, HER2-negative, node-positive resected early breast cancer at high risk of recurrence.

The primary efficacy endpoint was invasive disease-free survival (IDFS); IDFS for those receiving Verzenio plus endocrine therapy was 86.1 percent compared to 79 percent for those receiving endocrine therapy alone.

Overall survival data were not yet mature at the time of the IDFS data analysis. However, data supporting this approval was scheduled to be presented at the October 14 European Society for Medical Oncology (ESMO) Virtual Plenary.

The fight against cancer received another major boost with FDA’s approval of ChemoCentryx’s Tavneos (Avacopan) and Merck’s Keytruda (Pembrolizumab) for adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, and recurrent or metastatic cervical cancer respectively.

ANCA-associated vasculitis is a group of three autoimmune diseases – granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis – affecting small blood vessels.

They can result in organ damage and failure, particularly with the kidneys, and eventually death, if not treated.

Tavneos was approved for GPA and MPA based on findings from the ADVOCATE trial, a Phase 3 randomized, double-blind, active-controlled, double-dummy trial in which 331 patients.

 Each patient from the indicated population were randomized 1:1 to receive Tavneos or oral prednisone in combination with either cyclophosphamide (followed by azathioprine) or rituximab.

Merck’s Keytruda is also newly approved as a single agent for patients with recurrent or metastatic Programed Death Ligand (PD-L1)-expressing cervical cancer with progression on, or after completion of chemotherapy.

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