Lilly said it would test its investigational breast cancer treatment Abemaciclib in patients with metastatic castrate-resistant prostate cancer in Korea.
The Ministry of Food and Drug Safety approved Lilly Korea to conduct a phase-2 trial on LY2835219 Capsule on Tuesday.
The study will administer either a combination of Abemaciclib with abiraterone acetate and prednisone or abiraterone acetate and prednisone alone to the patients at Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital.
Abemaciclib is a new-class anticancer drug that inhibits CDK (cyclin-dependent kinase) 4 or CDK 6. The CDK 4 or CDK 6 is a protein that induces cell proliferation.
Suppressing CDK 4 or CDK 6 could prevent cancer cells from uncontrollably proliferating through excessive cell divisions, the company said. In an experiment on mice, decreased activities of CDK 4 and CDK 6 prevented certain types of tumors including breast cancer.
Lilly is developing Abemaciclib as the treatment for hormone receptor-positive and human epidermal growth factor receptor (HER-2)-negative breast cancer. The company received the Priority Review designation from the U.S.
Food and Drug Administration. Besides breast cancer, the company is testing the drug in patients with non-small cell lung cancer and pancreatic cancer.
In Korea, the drugmaker is conducting a phase-3 study to compare the standard endocrine therapy alone with the standard treatment combined with Abemaciclib in patients with hormone receptor-positive and human epidermal growth factor receptor (HER-2)-negative breast cancer. Lilly Korea obtained the approval for the trial in June.
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