Good news for Lilly on novel breast cancer therapy
Shares of US pharma major Eli Lilly (NYSE: LLY) ticked upwards on news that the company’s breast cancer candidate abemaciclib has performed well in a Phase III study.
Abemaciclib (see structure) is a CDK 4 and CDK 6 inhibitor, a new kind of therapy that scientists believe have a lot of potential in oncology.
The first therapy of this type to receive approval was Ibrance (palbociclib), which brought in $643 million in sales for Pfizer (NYSE: PFE) in 2016. Last week, the US Food and Drug Administration gave Novartis (NOVN: VX) approval for Kisqali (ribociclib) in breast cancer.
The pivotal trial evaluated abemaciclib in combination with anti-estrogen medication fulvestrant in women with a certain kind of advanced breast cancer who have relapsed or progressed after endocrine therapy.
The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically-significant improvement in progression-free survival.
The company intends to apply for regulatory approval in the USA for single-agent abemaciclib in the coming months. In 2015, the FDA granted abemaciclib Breakthrough Therapy designation.
Levi Garraway, senior vice president at Lilly Oncology, said: "We are excited about the outcome of our first Phase III study for abemaciclib. These data are an important milestone in our goal of bringing abemaciclib to patients with advanced breast cancer, and we look forward to our upcoming conversations with regulators.”