Oncternal Therapeutics Gets FDA Fast-Track on Prostate Cancer Treatment

By Dean Seal

Oncternal Therapeutics said regulators have granted its fast-track designation for ONCT-534, a treatment for patients with relapsed or refractory metastatic castration-resistant prostate cancer.

The San Diego-based clinical-stage biopharmaceutical company said the special status from the U.S. Food and Drug Administration will fast-track development of the treatment for patients who are resistant to approved androgen receptor pathway inhibitors.

The FDA's fast-track designation facilitates development and expedites the review of drugs that treat serious or life-threatening conditions and fill unmet medical needs.

"We believe that due to ONCT-534's novel mechanism of action, it may address important androgen receptor escape mechanisms that result in resistance to currently approved ARPIs," Chief Executive James Breitmeyer said.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

10-26-23 0925ET