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Updated results from the phase II LuPSMA study published in<em> The Lancet Oncology </em>showed radionuclide treatment with Lutetium-177 [<sup>177</sup>Lu]-PSMA-617 nearly doubled median PSA progression-free survival in men with progressive metastatic castrate-resistant prostate cancer compared with previous results with another radiopharmaceutical, radium-223.

CB-839 has been granted Fast Track designation by the FDA in combination with cabozantinib for the treatment of patients with metastatic renal cell carcinoma who have received 1 or 2 prior lines of therapy, according to Calithera Biosciences, the manufacturer of the first-in-class glutaminase inhibitor.

Antibiotics administered within 30 days of initiating treatment with PD-1 and PD­-L1 inhibitors were associated with poorer survival and increased risk for disease progression in patients with renal cell carcinoma or non-small cell lung cancer.

Molecular tumor profiling is rapidly driving personalized medicine within oncology. The value of identifying a targetable mutation using next-generation sequencing for available therapies or clinical trials cannot be underestimated. Herein, we review essential considerations in the initial assessment, specialty referral, and sequencing of treatment for advanced prostate cancer with an identified actionable mutation.

A 4-week dosing schedule for nivolumab has been approved by the European Commission for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma, Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.

Reviewers Commentary: This article adds to the growing body of literature on the role of PARP inhibitors in tumors with DNA repair defects.

The phase III ADAPT trial investigating rocapuldencel-T in patients with metastatic renal cell carcinoma has been stopped by Argos Therapeutics after findings of an interim analysis revealed the immunotherapy was unlikely to meet any of the primary endpoints.

Neeraj Agarwal, MD, recently discussed the treatment considerations and decisions he makes when treating patients with renal cell carcinoma. Agarwal, director of the Genitourinary Oncology Program, University of Utah School of Medicine, explained his treatment decisions based on a case scenario during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

Based on data from the phase III CheckMate-214 trial, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has been approved by the FDA as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

According to findings from the phase III ATLAS trial, disease-free survival was not extended with adjuvant axitinib (Inlyta) versus placebo for patients at high risk of recurrent renal cell carcinoma after nephrectomy.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.






Prostate Cancer

Based on data from the phase III PROSPER trial, a supplemental new drug application for enzalutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer has been granted a priority review by the FDA, according to Pfizer and Astellas, the companies developing the antiandrogen agent.

































