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GENITOURINARY CANCERS

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Based on findings of the phase III CheckMate-214 trial, a supplemental biologics license application for the combination of nivolumab and ipilimumab has been granted a priority review by the FDA as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

Combining the PD-1 inhibitor nivolumab (Opdivo) with the novel IDO inhibitor BMS-986205 generated promising response rates in patients with advanced cervical or bladder cancers and similar adverse effects to what is seen with anti–PD-1 monotherapy, according to findings of an early-phase clinical trial presented by Jason J. Luke, MD, during the SITC 32nd Annual Meeting.

A multidisciplinary set of guidelines for the treatment of patients with nonmetastatic muscle-invasive bladder cancer has been created as a result of a new collaboration between the American Urological Association and several other prominent urological groups. The new guidelines provide a risk-stratified clinical framework to better diagnose, treat, and manage the disease. 

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.