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FDA grants breakthrough therapy designation to abemaciclib for breast cancer
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The FDA granted breakthrough therapy designation to abemaciclib for treatment of patients with refractory hormone receptor-positive advanced or metastatic breast cancer.
The agency based its decision on results of the phase 1 JPBA trial, which evaluated abemaciclib (Eli Lilly) — a cyclin-dependent kinase 4 and 6 inhibitor — in women with advanced or metastatic breast cancer. Study participants had received a median seven prior systemic treatments.
Abemaciclib also is under investigation in three later-stage trials.
The phase 2 MONARCH 1 trial is designed to evaluate abemaciclib monotherapy for women with HR-positive, HER-2–negative metastatic breast cancer.
The phase 3 MONARCH 2 trial is designed to assess abemaciclib plus fulvestrant in postmenopausal women with HR-positive, HER-2–negative advanced or metastatic breast cancer.
The phase 3 MONARCH 3 is designed to assess abemaciclib plus a nonsteroidal aromatase inhibitor in patients with HR-positive, HER-2–negative locoregionally recurrent or metastatic breast cancer.
“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, 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,” Richard Gaynor, MD, senior vice president of product development and medical affairs for Lilly Oncology, said in a press release. “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.”