Urology Product Preview

FDA committee to review kidney cancer treatment
AVEO Oncology and Astellas Pharma Global Development, Inc., have announced that the FDA’s Oncologic Drugs Advisory Committee will review the companies’ new drug application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma during its meeting on May 2, 2013. According to the timelines established by the Prescription Drug User Fee Act, the review of the NDA is expected to be complete by July 28, 2013, the companies said.

Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a phase III clinical study in advanced RCC have been reported. It is also being evaluated in other tumors.

No significant safety concerns found in phase III trials of BPH agent
A Safety Monitoring Committee meeting held in February to review safety data from phase III trials of the investigational BPH drug NX-1207 was favorable and indicated no significant safety concerns to date, according to manufacturer Nymox Pharmaceutical Corp. The company also reported that clinical immunogenicity testing of men in the phase III trials showed no abnormalities.

Agent for OAB, incontinence yields positive top-line phase II results
TheraVida, Inc. reported positive results from a phase II clinical trial of its lead product candidate Tolenix (THVD-201) for the treatment of overactive bladder and urge urinary incontinence. Tolenix is a twice-daily proprietary combination of tolterodine, a muscarinic antagonist used to treat OAB, and pilocarpine, a muscarinic agonist approved to treat dry mouth (xerostomia).

Patients receiving Tolenix experienced statistically significant improvements in their OAB and urinary incontinence symptoms over placebo control, as well as efficacy similar in magnitude to the maximum dose of active control tolterodine tartrate (Detrol). Patients receiving Tolenix also demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects, as compared to tolterodine, TheraVida reported.

Phase II findings show kidney cancer agent prolongs survival
Updated results from a phase II study of AGS-003, for the treatment of metastatic renal cell carcinoma, continue to show prolonged survival in patients with unfavorable-risk disease, with one-third of patients still alive after nearly 4 years or longer, according to manufacturer Argos Therapeutics. Findings were presented at the Genitourinary Cancers Symposium in Orlando, FL.

FDA to review new drug application for extended-release tacrolimus
The FDA has accepted for review Astellas Pharma US, Inc.’s new drug application (NDA) for tacrolimus (Prograf) extended-release capsules, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Based upon the September 2012 receipt of the NDA submission, the FDA Prescription Drug User Fee Act review date will be July 21, 2013. Developed by Astellas, tacrolimus extended-release capsules are a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus.