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When checkpoint inhibitors<strong>&nbsp;</strong>were introduced, it had been more than 30 years since any new drugs had been approved for the treatment of urothelial cancer. Recently, 2 new non&ndash;checkpoint inhibitors, erdafitinib and enfortumab vedotin-ejfv, reached the market, and more may be available soon.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

According to results from the phase III DANUBE bladder cancer trial, neither of the co-primary end points of the trial were met. The combination of durvalumab, and tremelimumab did not show an improvement in overall survival in treatment-na&iuml;ve patients with unresectable, stage IV bladder cancer. Also, durvalumab alone failed to show an OS benefit over standard-of-care chemotherapy alone in patients with high PD-L1 expression.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Stephen Boorjian, MD, discusses the efficacy results of the phase II study intravesical nadofaragene firadenovec in patients with high-grade, Bacillus Calmette-Guerin unresponsive nonmuscle invasive bladder cancer, which he presented at the 2020 Genitourinary Cancer Symposium.&nbsp;

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Tremelimumab monotherapy showed clinical activity with durable responses in patients with metastatic urothelial carcinoma and documented transitional cell carcinoma of the urothelium who failed first-line platinum-based chemotherapy, according to results from a phase II study, which is evaluating the drug in solid tumors.