Author Archives: urologyadmin

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 […]

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 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 […]

Comments: This is not a Urology Update. The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a […]

Comments: The U.S. FDA has granted Disitamab Vedotin (RC48) a breakthrough therapy designation for the treatment of patients with HER2-positive locally advanced or metastatic urothelial carcinoma following treatment with platinum-based chemotherapy. This does not equate to approval of the product, but will expedite the development and review of disitamab vedotin in this setting.  Dr Rajeentheran […]

Comments – another drug option for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Kindly note this is for SUPERFICIAL (non-muscle-invasive) bladder cancers. Muscle-invasive bladder cancers will still […]

Comments: Olaparib increases overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had tumors with at least 1 alteration in BRCA1, BRCA2, or ATMgenes, according to a final analysis of the PROfound trial. Do note that On May 19, 2020, the FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with […]

Comments: Final overall survival data (OS) from the phase 3 ARAMIS trial showed that adding darolutamide (Nubeqa) to androgen deprivation therapy (ADT) led to a 31% reduction in the risk of death compared with ADT alone in patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to results published in the New England Journal of Medicine. […]

 “The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients” Median progression free survival among patients with advanced RCC (Renal Cell Cancer), which was the trial’s primary […]

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer.