Monthly Archives: November 2020

Mitomycin Gel for Low-Grade Upper Tract Urothelial Carcinoma

Tumor-ablative chemotherapy for low-grade upper tract urothelial carcinoma (UTUC) using a mitomycin gel formulation approved earlier this year results in a high rate of durable complete response without significant safety issues, according to a urologist who spoke about the treatment at an industry symposium during the Large Urology Group Practice Association’s 2020 virtual annual meeting. […]

FDA approves lumasiran as first drug for primary hyperoxaluria type 1

Supported by data from the phase 3 ILLUMINATE-A and ILLUMINATE-B studies, the FDA has approved lumasiran (Oxlumo) as the first drug for the treatment of patients with primary hyperoxaluria type 1 (PH1). The drug is approved for both adult and pediatric patients. Patients with primary hyperoxaluria type 1 produce excess oxalate, which, when combined with […]

FDA approves less-frequent dose of durvalumab

Durvalumab is now approved for a dosing schedule of 1500 mg every 4 weeks. Previously approved regimens require patients to received treatment every 2 weeks. The approval was based on several clinical trials of durvalumab, including the phase 3 PACIFIC trial in non–small cell lung cancer (NSCLC) and the phase 3 CASPIAN trial in extensive-stage […]

Vibegron update shared as FDA weighs approval in OAB

Vibegron is a selective beta 3 adrenergic receptor (β3AR) agonist. Just like Mirabegron, another drug in the same class, it is being developed for OAB. An extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting showed that at week 52, 61% of patients receiving vibegron had […]

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