On October 8, 2015 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (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 (Press release, Eli Lilly, OCT 8, 2015, View Source [SID:1234507665]). Schedule your 30 min Free 1stOncology Demo! 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.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
"If caught before it spreads, patients can survive breast cancer. However, for the nearly 10 percent of patients who are initially diagnosed at stage IV,1 and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease,1 there remains an urgent need for effective therapy options," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "We are pleased that the FDA has designated abemaciclib as a breakthrough therapy for patients with advanced breast cancer and Lilly will work closely with the FDA in this process to expedite its development and review."
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.
About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. each year, nearly 232,000 new cases of invasive breast cancer will be diagnosed and about 40,000 women will die from breast cancer.3 Of all diagnosed breast cancer cases in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.1 Metastatic breast cancer is considered incurable, but is generally treatable.
About Abemaciclib
Cyclin-dependent kinases play a key role in regulating cell cycle progression. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and 6. Lilly’s 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. Results from preclinical and early-stage clinical studies support the further evaluation of abemaciclib for the treatment of human cancers – including breast cancer and lung cancer – in which aberrant CDK 4 and 6 pathways enhance cancer cell growth. Abemaciclib has now entered into Phase III development with two trials in HR+ breast cancer patients, as well as a Phase III trial in lung cancer.