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    Uro Pipeline: FDA accepts priority review application for RCC treatment


    FDA grants breakthrough designation to RCC treatment

    The FDA has granted breakthrough therapy designation for avelumab in combination with axitinib (INLYTA) for treatment-naïve patients with advanced renal cell carcinoma (RCC). The designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global phase Ib study assessing the safety and efficacy of avelumab in combination with axitinib for the treatment of treatment-naïve patients with advanced RCC. Updated results from this phase Ib study were presented at the 2017 American Society of Clinical Oncology annual meeting in Chicago. 

    Phase I trial underway for prostate cancer immunotherapy

    Researchers at Roswell Park Cancer Institute, Buffalo, NY, and several other sites are conducting a phase I clinical trial of an immunotherapy for men with metastatic prostate cancer that has progressed in spite of standard treatment. The trial centers on MOR209/ES414, a special type of antibody that researchers hope will guide the patient’s T cells to seek out prostate-specific membrane antigen. The science behind the clinical trial is based on results of clinical trials for a similar immunotherapy called blinatumomab (Blincyto), which is FDA-approved for the treatment of acute lymphoblastic leukemia. Participants receive MOR209/ES414 in a continuous infusion through a pump that’s worn as a “fanny pack” and visit the GU Center at Roswell Park twice per week for 6 months.

    Positive results reported for phase II clinical trial of SUI agent

    GTx, Inc. recently provided updates on its investigational products for stress urinary incontinence (SUI) and prostate cancer products. It reported positive results from the phase II proof-of-concept clinical trial of oral enobosarm, 3 mg, in postmenopausal women with SUI. The company has initiated a second clinical trial, Assessing Enobosarm for Stress Urinary Incontinence Disorder (ASTRID): a randomized, double-blinded, placebo-controlled, phase II trial to assess the efficacy and safety of two doses of enobosarm (1 mg and 3 mg) administered orally in postmenopausal woman with SUI compared to placebo. In addition, GTx has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer. The company said it has ongoing mechanistic preclinical studies designed to select the most appropriate compound to advance into a first-in-human clinical trial.

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