FDA grants priority review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer
With a priority review, the FDA will make a decision about the approvability of apalutamide on about April 10, 2018, six months from the acceptance of the new drug application. Additionally, an oral presentation at the upcoming Genitourinary Cancers Symposium in early February will provide a full report on the results of the SPARTAN trial. Last year, Janssen announced positive results from the SPARTAN trial.
OLYMPUS trial is open for enrollment for patients with low-grade upper tract urothelial carcinoma for treatment with MitoGel,™ a gel formulation of mitomycin for ureteral instillation.
FDA Grants De Novo request for PROCEPT BioRobotics AQUABEAM® System
PROCEPT BioRobotics AQUABEAM® System’s Aquablation® technology offers heat-free robotic alternative for the minimally invasive treatment of benign prostatic hyperplasia.