Russ Conroy

Novel targeted therapy BT8009 granted FDA Fast Track Designation for urothelial cancer.

The FDA’s Fast Track Designation is designed to expedite the review and development of novel treatments that will fill an unmet medical need.

177Lu-PSMA-617 is approved by the FDA for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting.

The findings are from the phase 2/3 FORT-1 study published in the Journal of Clinical Oncology.

The trial prospectively included a subgroup analysis comparing patients who received SBRT using robotic non-coplanar radiotherapy (CyberKnife) compared with conventional linear accelerator.