Priority review for Lilly's breast cancer hopeful

The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and granted it a Priority Review designation.

In its NDA, the drug’s developer Eli Lilly (NYSE: LLY) includes the submission of abemaciclib for two indications, firstly as a 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. Also included is the submission for abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy. The NDA is based on the MONARCH 1 and MONARCH 2 studies, respectively.

Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology, said: “We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy for patients with advanced breast cancer.