Urothelial Cancer

On April 3, 2023, the FDA accelerated the approval of a new indication for enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, with pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. Read More ›

Although standard chemotherapy is often effective in the first-line treatment of locally invasive urothelial carcinoma, until recently, there have been few second- or third-line treatment options for patients with advanced or metastatic disease. During the 2021 Hematology/Oncology Pharmacy Association Annual Conference, Renee K. McAlister, PharmD, BCOP, Oncology Clinical Pharmacy Specialist, Melanoma/Genitourinary Oncology Clinics, Vanderbilt University Medical Center, Nashville, TN, discussed promising results from clinical trials evaluating the use of erdafitinib (Balversa) and enfortumab vedotin (Padcev), 2 FDA-approved drugs that are changing the therapeutic landscape for metastatic urothelial cancer. Read More ›

In patients with metastatic urothelial cancer who received previous therapy, as well as in cisplatin-ineligible patients with this cancer, enfortumab vedotin-ejfv (Padcev) improved overall survival (OS), according to new data presented at the 2021 ASCO Genitourinary Cancers Symposium. The data come from the phase 3 EV-301 study and cohort 2 of the phase 2 EV-201 study. Experts believe this antibody–drug conjugate will become a new standard of care in the treatment of patients with advanced urothelial cancer. Read More ›

Combining the antibody drug conjugate, enfortumab vedotin (Padcev) with the immune checkpoint inhibitor pembrolizumab (Keytruda) showed encouraging results in patients with locally advanced or metastatic uro­thelial cancer who were unable to receive cisplatin-based chemotherapy in the first-line setting.

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Preliminary results from a single-arm study demonstrated promising progression-free survival (PFS) and a clinically meaningful objective response rate (ORR) with the combination of pembrolizumab (Keytruda) and nab-paclitaxel (Abraxane) as second- or third-line therapy in patients with advanced urothelial carcinoma.

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On June 30, 2020, the FDA approved avelumab (Bavencio; Pfizer) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval was based on results of the randomized, multicenter, open-label, phase 3 JAVELIN Bladder clinical trial. This study enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized to avelumab given intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.

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Mitomycin gel (Jelmyto), an alkylating drug, is the first and only FDA-approved treatment for patients with low-grade upper-tract urothelial cancer (UTUC), a rare cancer that affects the lining of the urinary system, and offers a nonsurgical treatment alternative for patients with this rare disease. Although the majority of urothelial cancers occur in the bladder, UTUC is part of a group of urothelial cancers that arise in the lining of the kidney or the ureter. Read More ›

Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

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Sacituzumab govitecan, a novel antibody-drug conjugate directed against Trop-2, induced responses in nearly 33% of patients with heavily pretreated, relapsed or refrac­tory metastatic urothelial cancer. Read More ›

Adjuvant chemotherapy had impressive gains in disease-free survival (DFS) and metastasis-free survival versus surveillance in upper-tract urothelial cancer (UTUC), according to the results of the phase 3 POUT clinical trial that were presented at the 2018 Genitourinary Cancers Symposium. Read More ›