The FDA has granted Priority Review designation for Eli Lilly and Company’s New Drug Application (NDA) for Verzenio (abemaciclib), a cyclindependent kinase 4 and 6 inhibitor for metastatic breast cancer. The decision was based on the MONARCH 3 study, which examined abemaciclib as an initial endocrine-based therapy.
The FDA has granted Priority Review designation for Eli Lilly and Company’s New Drug Application (NDA) for Verzenio (abemaciclib), a cyclindependent kinase (CDK) 4 and 6 inhibitor for metastatic breast cancer.
The FDA’s decision was based on the positive interim results of the MONARCH 3 study, which examined abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for treating women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
"On the heels of our recent FDA approval of Verzenio, we are pleased with this important step forward in the agency's consideration to expand the use of Verzenio in metastatic breast cancer," Levi Garraway, MD, PhD, senior vice president, global development and medical affairs, Lilly Oncology, said in a statement. "We look forward to ongoing collaboration with the FDA to advance this important treatment across the spectrum of care for patients living with advanced or metastatic breast cancer."
Verzenio was developed to disrupt the cell cycle. When dosed daily as a single agent or in combination with antiestrogens, the treatment has been found to reduce tumor size in patients. This treatment could potentially be used to treat breast cancer—the most frequently diagnosed cancer in women worldwide.
The MONARCH 3 study results were originally presented at the European Society for Medical Oncology (ESMO) 2017 Congress, and later published in the Journal of Clinical Oncology.
"The significant results seen in MONARCH 3 confirm the clinical value of combining abemaciclib with an aromatase inhibitor in patients with endocrine-sensitive advanced breast cancer, and we look forward to seeing the final PFS data in the coming months," lead author Matthew P. Goetz, MD, professor of oncology and pharmacology at Mayo Clinic and co-lead investigator of the MONARCH 3 study, said in a statement. "These data further demonstrate that abemaciclib is an effective treatment in the CDK4 and 6 class. This class represents a new standard of care in the treatment of advanced breast cancer."
The Priority Review that the FDA granted Verzenio is intended to expedite the review of applications for the drug due to the significance advance in treatment. Additionally, Priority Review of a new drug allows the FDA to take action within 8 months of receiving the application while the standard review time is 12 months.