The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monotherapy treatments in patients with locally advanced or metastatic urothelial carcinoma," began Christopher Hoimes, Associate Professor of Medicine at t...

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...

The FDA has granted regular approval to nivolumab (Opdivo®, Bristol Myers Squibb) as adjuvant therapy for patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. This is the first time the FDA has approved an adjuvant treatment for patients with high-risk urothelial carcinoma. Nivolumab had previously been granted accelerated approval for advanced and metastatic urothelial cancer. "In a phase 3, multicenter, double-blind, randomized, controlled t...

The FDA has granted regular approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma US, Inc.) for patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy or those who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. "Patients with locally advanced or metastatic ur...

Recently, the FDA granted accelerated approval to sacituzumab govitecan (Trodelvy®, Immunomedics), an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer whose disease progressed following treatment with platinum-containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitor. In this interview with Oncology Data Advisor, Dr. Petros Grivas, Associate Professor and Clinical Director of the Genitourinary Cance...

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...

Upper-tract urothelial cancer (UTUC) is a rare cancer that often needs to be treated with radical surgery, typically entailing complete removal of the affected kidney, ureter, and bladder cuff. Mitomycin C formulated with a reverse thermal hydrogel (JelmytoTM, UroGen Pharma), recently approved by the FDA as the first agent specifically indicated for the treatment of low-grade UTUC, will now allow some patients to keep a kidney that would otherwise have needed to be removed. In this interview wit...

The FDA has now approved mitomycin C formulated with a reverse thermal hydrogel (JelmytoTM, UroGen Pharma) for the treatment of adults with low-grade upper tract urothelial cancer (UTUC). Accounting for 5% to 10% of all urothelial cancers, UTUC is a rare disease; low-grade UTUC occurs at an incidence of 6,000 to 8,000 cases per year in the United States. Mitomycin C hydrogel, the first drug to be approved specifically for low-grade UTUC, is an alkylating agent, a drug that halts protei...

Erdafitinib (Balversa™, Janssen Pharmaceutical Companies) was recently granted FDA approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Erdafitinib targets genetic alterations that occur in FGFRs, which regulate important biological processes, including cell g...

A phase 1a/b trial (NCT02443324) reports that ramucirumab in conjunction with pembrolizumab is effective in patients with previously treated advanced non-small cell lung cancer (NSCLC), gastroesophageal cancer, or urothelial carcinomas. Ramucirumab, a monoclonal antibody, blocks vascular endothelial growth factor receptor 2 (VEGFR2), which allows cancer cells to grow and metastasize. Pembrolizumab is also a monoclonal antibody, but it works by blocking programmed cell death protein-1 (PD-1), in ...

For many patients with metastatic urothelial carcinoma, cisplatin-containing chemotherapy is not an option; alternative treatments are greatly needed. Recently, the phase 2 California Cancer Consortium trial, led by Sarmad Sadeghi, MD, PhD, reported that a combined regimen of gemcitabine (Gemzar®, Eli Lilly) and eribulin (Halaven®, Eisai Inc.) demonstrates efficacy in cisplatin-ineligible patients with metastatic urothelial carcinoma. In this interview with i3 Health, Dr. Sadeghi discusses the i...