Prostate Cancer

Based on data from the phase III SPARTAN trial, apalutamide has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

According to results of a phase I/II study, men with metastatic castration-resistant prostate cancer who received a second course of radium-223 (Xofigo) experienced minimal hematologic toxicity and low radiographic bone progression rates.

Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer, the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

A look back at all the FDA news that occurred in the month of September.

Optimal Use of Bone-Targeted Therapy for mCRPC

mCRPC Treated with Concomitant ADT and Radium-223 Therapy

Based on phase III results from the PROSELICA trial, the FDA has approved the combination of cabazitaxel at a dose of 20 mg/m² every 3 weeks and prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen.

An analysis of the genomic landscape of patients with prostate cancer shows that tumors separated into 3 clusters that aligned with the luminal A, luminal B, and basal subtypes found in breast cancer tumors, according to a presentation during the 2017 American Urological Association Annual Meeting.

Based on results of a feasibility study, researchers in the United Kingdom have decided to move forward with a full randomized controlled trial comparing partial prostate ablation (PA) with radical prostatectomy (RP) in patients with intermediate-risk prostate cancer, according to a presentation at the 2017 American Urological Association Annual Meeting.

Results of an investigation presented at the 2017 American Urological Association Annual Meeting indicate that resistance to docetaxel and cabazitaxel (Jevtana) in patients with castration-resistant prostate cancer (CRPC) is mediated by a common mechanism, overexpression of the ABCB1 gene.