Drug for CRPC Receives FDA Fast-Track Designation

The FDA has given fast-track designation to galeterone (TOK-001), a small molecule, oral drug for the treatment of castrate-resistant prostate cancer (CRPC).

In the phase 1 ARMOR (Androgen Receptor Modulation Optimized for Response) study, galeterone demonstrated efficacy and was well tolerated in CRPC patients. Results of the study were presented recently at the American Society of Clinical Oncology annual meeting as well as the American Association for Cancer Research annual meeting.

Galeterone works by preventing testosterone synthesis, antagonizing testosterone binding to the androgen receptor, and degrading the androgen receptor protein.

Developed by Tokai Pharmaceuticals in Cambridge, Mass., the drug will enter a phase 2 trial later this year, according to a press release issued by the company.

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