Genitourinary Cancer

The FDA today granted accelerated approval to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

FDA’s Oncologic Drugs Advisory Committee plans to hold a public meeting April 27-29 to review six indications for cancer drugs granted accelerated approval that subsequently failed to show clinical benefit in confirmatory trials.

The FDA granted priority review to belzutifan for treatment of certain patients with renal cell carcinoma.

The FDA approved tivozanib for treatment of adults with relapsed or refractory advanced renal cell carcinoma.

Genentech voluntarily withdrew atezolizumab’s indication in the United States for patients with platinum-treated metastatic urothelial carcinoma.

Pembrolizumab monotherapy showed promising antitumor activity and durable response rates as initial treatment for both clear cell and non-clear cell advanced renal cell carcinoma.

AstraZeneca voluntarily withdrew durvalumab’s indication for treatment of adults with locally advanced or metastatic bladder cancer.

Adjuvant nivolumab extended DFS compared with placebo among patients with high-risk, muscle invasive urothelial carcinoma, according to results of the phase 3 CheckMate 274 trial presented at Genitourinary Cancers Symposium.

Cabozantinib conferred a significant and meaningful extension of PFS compared with sunitinib in metastatic papillary renal cell carcinoma, according to results of a phase 2 randomized trial presented at Genitourinary Cancers Symposium.

The combination of lenvatinib and pembrolizumab significantly prolonged OS and PFS compared with sunitinib among previously untreated patients with advanced renal cell carcinoma, according to results of the phase 3 CLEAR trial.