Currently Viewing:
Newsroom
Currently Reading
Lack of Payer Support a Barrier to Diabetes Prevention, CDC Reports
December 17, 2017 – Mary Caffrey
Pfizer Announces Phase 3 Trial for Atopic Dermatitis Treatment
December 15, 2017 – Samantha DiGrande
Average Profit Margin on Oncology Drugs For 340B Hospitals Nears 50%
December 15, 2017 – Jaime Rosenberg
Majority of Women With Breast Cancer Surgery Did Not Feel Fully Informed of Treatment Options
December 15, 2017 – Jaime Rosenberg
AJMC® in the Press, December 15, 2017
December 15, 2017 – AJMC Staff
What We're Reading: Medicare Lab Testing; CHIP Deadline; AMA Expands Diabetes Efforts
December 15, 2017 – AJMC Staff
5 Key Takeaways From ASH 2017
December 15, 2017 – Surabhi Dangi-Garimella, PhD
This Week in Managed Care: December 15, 2017
December 15, 2017
What We're Reading: Medical Device Tax; Marijuana and Vaping; Birth Control Without Prescriptions
December 14, 2017 – AJMC Staff

FDA Grants Priority Review for Lilly's Verzenio for Metastatic Breast Cancer

Alison Rodriguez
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.

 
Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!