Type of information: Acceptation for review of a NDA
Product name: abemaciclib (LY2835219)
Therapeutic area: Cancer - Oncology
- cell cycle inhibitor/cyclin dependant kinase inhibitor. Abemaciclib (LY2835219) is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6, the results from the cell-free enzymatic assays have shown that it was most active against Cyclin D 1 and CDK 4.
Company: Eli Lilly (USA -IN)
Disease: refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer
- • On July 10, 2017, Eli Lilly announced that the FDA has accepted and filed its New Drug Application (NDA) for abemaciclib, and given the NDA a Priority Review designation. The NDA includes the company's submission of abemaciclib for two indications:
- - abemaciclib monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease;
- - and for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. This submission is based on the MONARCH 1 and MONARCH 2 studies, respectively.
- 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.1 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.
• On October 8, 2015, Eli Lilly announced that the FDA has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company's Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.
- Lilly has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II trial evaluating the use of abemaciclib as monotherapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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Favourable opinion USA:
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Orphan status UE:
Pediatric exclusivit _USA:
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