Posted by Michael Wonder on 30 Sep 2021
FDA grants priority review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer
28 September 2021 - Novartis announced today that the US FDA has accepted and granted Priority Review to the company’s New Drug Application for 177Lu-PSMA-617, an investigational targeted radio-ligand therapy for the treatment of metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting.
With Priority Review, the Prescription Drug User Fee Act date is anticipated in the first half of 2022.
