Oncternal Therapeutics Receives FDA Study May Proceed Letter for ONCT-534, its Novel Dual-action Androgen Receptor Inhibitor, for the Treatment of Patients with Advanced Prostate Cancer
Retrieved on:
Thursday, August 3, 2023
The letter was received prior to the 30-day review date.
Key Points:
- The letter was received prior to the 30-day review date.
- “We are very pleased with the FDA’s authorization to proceed with our Phase 1/2 clinical trial of ONCT-534,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.
- “Many men suffering from prostate cancer that has relapsed or is refractory after treatment with standard of care ARSI therapy, such as enzalutamide or abiraterone, need additional treatment alternatives.
- We believe that ONCT-534’s novel mechanism of action may help address key tumor escape mechanisms that cause such resistance.