Jason M. Broderick

The designation is for patients with mCRPC who have progressed on an androgen receptor pathway inhibitor and are not eligible for or decline to receive chemotherapy.

The PSMA-targeted fluorescent tracer OTL78 was shown to be safe and enabled real-time imaging during robot-assisted radical prostatectomy and provided valuable information on the localization and extent of prostate cancer.

Clinical guidelines currently do not recommend PSMA-PET imaging before radical prostatectomy.

“We recommend mirabegron monotherapy as an alternative medical treatment choice for the management of OAB,” the authors wrote.

Availability, expertise, and funding were the primary issues identified as barriers to use of sacral neuromodulation for the treatment of patients with overactive bladder.

The phase 2 LITESPARK-003 study explored belzutifan plus cabozantinib in patients with locally advanced or metastatic clear cell renal cell carcinoma.

The approval of pembrolizumab plus enfortumab vedotin in urothelial cancer was supported by results from the EV-103/KEYNOTE-869 trial.

Apalutamide is approved by the FDA for the treatment of patients with non-metastatic castration-resistant prostate cancer or metastatic castration-sensitive prostate cancer.

Prostate cancer, bladder cancer, renal cell carcinoma were among the multitude of tumor types assessed in the analysis supporting the approval.

The PSMA-targeted monoclonal antibody J591 is effective in non-metastatic CRPC when it is radiolabeled with either 177Lu or 111In.

The enzalutamide/leuprolide combo also led to statistically significant improvements in time to PSA progression and time to start of new antineoplastic therapy.

The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom 177Lu-PSMA-617 is indicated.

"While past global studies have supported the use of Xtandi plus ADT in men with mHSPC, it is encouraging to see these results replicated for patients in mainland China," said Zhou Fangjian, MD.

Avelumab is approved by the FDA as a maintenance therapy for patients with locally advanced/metastatic urothelial carcinoma that has not progressed with first-line, platinum-based chemotherapy.

"These findings may directly inform clinical care, such as providing diet recommendations for managing health, and potentially offer other positive health benefits for preventing numerous chronic diseases,” said Bradley Alexander McGregor, MD.

The application is supported by findings from the phase 3 MAGNITUDE study.

The addition of pembrolizumab to enzalutamide and ADT did not extend survival or delay disease progression compared with enzalutamide and ADT alone.

"While the data are still early, EG-70's safety profile and efficacy are well on their way towards establishing a new benchmark for monotherapy treatment of high-risk NMIBC with BCG-unresponsive carcinoma in situ,” said lead study author Gary Steinberg MD.

The phase 1 PROPELLER trial assessed the safety and efficacy of 64Cu-SAR-bisPSMA, and compared the imaging agent with 68Ga-PSMA-11 PET.

The GPS test uses a 17-gene signature to predict disease aggressiveness and help guide treatment decisions for patients with localized prostate cancer.

IsoPSA is included in the National Comprehensive Cancer Network Prostate Cancer guidelines for early detection of the disease.

Patients in the trial received switch maintenance with darolutamide following prior taxane chemotherapy and at least 1 androgen-receptor pathway inhibitor.

"We are very pleased to have reached our recruitment target for the COBRA trial. The data generated thus far on the SAR-bisPSMA product is very encouraging and shows high uptake of the agent by prostate cancer cells,” said Neal Shore, MD.

The application for darolutamide in the European Union is supported by findings from the phase 3 ARASENS trial.

The double-blind phase 3 KEYNOTE-991 trial had enrolled 1251 patients.

The SPLASH trial is examining PNT2002 in patients whose tumors express PSMA and who have experienced disease progression on an androgen receptor axis–targeted therapy.

At the 2022 SUO Annual Meeting, Grant Stewart, MD, PhD, discussed the potential of neoadjuvant therapy as a tool to help optimize the management of patients with localized kidney cancer.

The TAVT-45 formulation of abiraterone acetate was created for patients with dysphagia, who would have difficulty swallowing a tablet.

Catch up on all the notable drug and device approvals in urology over the past year.

The European Commission based its approval on results from the phase 3 PROpel trial, which showed that adding olaparib to frontline abiraterone acetate and prednisone/prednisolone significantly improved radiographic progression-free survival in patients with mCRPC.