The US FDA has accepted Eli Lily’s New Drug Application (NDA) for its advanced breast cancer treatment and given it Priority Review.
The NDA includes the company’s submission of abemaciclib for two indications: abemaciclib monotherapy for patients with advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease; and for abemaciclib in combination with fulvestrant in women with advanced breast cancer who had disease progression following endocrine therapy.
This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.
In 2015, the FDA granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company’s Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer.
With Priority Review of a new drug, the FDA’s goal is to take action within eight months of receiving an application, compared with the standard review timeframe of 12 months.
Lilly is working closely with the FDA and anticipates agency action on this application in the first quarter of 2018.
In addition, Lilly intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of 2017.