Eli Lilly’s experimental breast cancer drug abemaciclib has been granted a priority review by US regulators for two indications, and is now on track to be filed in Europe later this year.
The US Food and Drug Administration will consider the drug’s use as 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 also in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.
The submissions are based on the Phase III Monarch I and II trials, the first of which showed that the cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor achieved an objective response rate of 19.7 percent and progression free survival of six months, while the second showed that adding abemaciclib to fulvestrant (AstraZeneca's Faslodex) cut the risk of disease progression or death by 45 percent versus the latter alone.
"Breast cancer is a complex disease, and the need still exists for new treatment options as patients face a significant disease burden,” said Levi Garraway, senior vice president of global development and medical affairs, Lilly Oncology. “We look forward to working with the FDA and bringing this important potential treatment option to patients as soon as possible.”
Lilly said intends to submit abemaciclib to European regulators in the third quarter of 2017 and to Japanese regulators before the end of the year.