FDA grants priority review to sNDA for prostate cancer treatment
Pfizer Inc. and Astellas Pharma Inc. recently announced that a supplemental new drug application (sNDA) for enzalutamide (XTANDI) has been accepted for filing and granted priority review designation by the FDA. If approved, the sNDA would expand the indication of enzalutamide to include men with non-metastatic castration-resistant prostate cancer (CRPC), based on data from the phase III PROSPER trial. Enzalutamide is currently indicated for the treatment of patients with metastatic CRPC. The PROSPER trial evaluated enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in 1,401 patients with non-metastatic CRPC. The study met its primary endpoint, demonstrating that the use of enzalutamide plus ADT significantly reduced the risk of developing metastasis or death compared to ADT alone.
Dosing initiated for clinical trial of muscle-invasive bladder Ca agent
TARIS Biomedical has initiated dosing in a clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer (MIBC) who are unfit for therapy with curative intent. The multicenter, multi-region study intends to enroll subjects with organ-confined, non-metastatic MIBC who are unfit for curative intent therapies. Subjects will be evaluated for safety, tolerability, and evidence of anti-tumor efficacy following four consecutive cycles of TAR-200. Subjects successfully completing this dosing period will then be eligible to receive additional maintenance dose cycles. The company has also engaged in a research collaboration with Uppsala Clinical Research Center and Per-Uno Malmström, MD, PhD, of Uppsala, Sweden. The collaboration will focus on better understanding the natural history and disease outcomes for patients diagnosed with MIBC, through analysis of Sweden’s National Registry of Urinary Bladder Cancer and BladderBaSe disease registries. Dr. Malmström will lead this effort.
Agent shows potential for treating mixed incontinence
GTx, Inc. has announced additional results from a phase II proof-of-concept clinical trial of enobosarm, 3 mg administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. New data in a subset of women also suggest a positive treatment effect of the selective androgen receptor modulator (SARM) for urge incontinence (UI), suggesting a possible treatment effect for women with mixed incontinence, according to GTx. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68% in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI. The data were presented at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction winter meeting in Austin, TX.