With FDA 'breakthrough' in hand, Eli Lilly shoots for accelerated abemaciclib OK

Eli Lilly's would-be rival to Pfizer's Ibrance (palbociclib) just gained an inside track at the FDA. Regulators handed Lilly the coveted "breakthrough therapy" designation for abemaciclib, another CDK 4/6 inhibitor with big plans for carving out a niche among patients with advanced breast cancer.

Ibrance's accelerated approval was one of the most encouraging news items to come out of Pfizer ($PFE) in several years. And the same targeted approach has excited analysts who have been pondering the rivalry that could develop with Lilly ($LLY) and Novartis ($NVS), which has been advancing ribociclib (LEE011).

According to Lilly, the FDA based its approval on Phase I data that was reviewed back in 2014. And now Lilly, which has enjoyed a few new drug approvals after a long drought, is hoping that it can use its new VIP status to help gain an accelerated approval of its own. Some analysts, though, have raised doubts about whether the drug can meaningfully differentiate itself from Pfizer's Ibrance. 

Lilly has mounted a Phase II trial, MONARCH 1, to study abemaciclib's impact as a monotherapy in women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. Lilly is also pursuing two late-stage studies for a combination of abemaciclib with fulvestrant and a nonsteroidal aromatase inhibitor.

"If caught before it spreads, patients can survive breast cancer," said Dr. Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology. "However, for the nearly 10 percent of patients who are initially diagnosed at stage IV, and the nearly 30 percent of patients whose early-stage cancer will re-occur as metastatic disease, there remains an urgent need for effective therapy options. 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."

- here's the release