NDA submitted for non-metastatic castration-resistant PCa agent
Janssen Biotech, Inc. has submitted a new drug application to the FDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). The submission is based on phase III data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo in men with non-metastatic CRPC who have a rapidly rising PSA despite receiving continuous androgen deprivation therapy. The primary endpoint of the study was metastasis-free survival. SPARTAN study results will be presented at a future medical meeting, according to Janssen Biotech.
Priority review granted for advanced renal cell carcinoma agent
The FDA has determined Exelixis, Inc.’s supplemental new drug application for cabozantinib (CABOMETYX) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted priority review of the filing and assigned a Prescription Drug User Fee Act action date of Feb. 15, 2018. The application is based on data from CABOSUN, a randomized phase II trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program. CABOMETYX was previously approved by the FDA on April 25, 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.
Study to evaluate 3-D printing of kidney, prostate models
Stratasys announced that a new clinical study is being conducted with the New York University School of Medicine, New York, aimed at advancing diagnosis and treatment of complex kidney and prostate tumors through imaging and 3-D printing. The 2-year clinical trial is specifically targeted at analyzing how patient-specific multi-colored physical tumor models, printed on the Stratasys J750 3-D printer, can potentially change and improve the quality of patient care. Under the randomized, controlled study, researchers are 3-D-printing kidney and prostate cancer models for a sample of the participating 300 patients—measuring the specific impact each has on pre-surgical planning versus traditional 2-D visualization approaches. Subjects are separated into three treatment categories to analyze and compare conventional preoperative 2-D imaging, augmented reality models, and next-generation 3-D printed models. The study is expected to continue into 2018, according to Stratasys.
FDA accepts supplemental NDA for bladder cancer detection agent
The FDA has accepted the supplemental new drug application for Photocure ASA’s Cysview on a priority review basis. Photocure said it is looking to expand the label of Cysview to include its use in the outpatient setting to detect the recurrence of bladder cancer using a flexible cystoscope, the detection of carcinoma in situ, and the repeat administration of Cysview. The filing is a combination drug-device application with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System. With the FDA granting a priority review, a decision is expected in the first half of 2018.
Imaging modality leads to changes in prostate cancer management
Results of a recent interim analysis showed that 61.2% (52/85) of prostate cancer patients had their clinical management changed when results of fluciclovine (18F) positron emission tomography/computed tomography imaging were added to the standard-of-care diagnostic workup. Results from the phase III FALCON trial were presented at the American Society for Radiation Oncology annual meeting in San Diego. The study is evaluating the clinical impact of fluciclovine (18F) PET/CT imaging on patient management decisions in men with biochemically recurrent prostate cancer, according to Blue Earth Diagnostics. Fluciclovine F 18 injection (Axumin) is an FDA-approved molecular imaging agent for use in PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. It is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.
Treatment underway for patients in clinical trial of BPH treatment
The first patients have been treated in the WATER II Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue). The WATER II study is a U.S. investigational device exemption clinical trial evaluating the safety and efficacy of Aquablation, delivered with PROCEPT BioRobotics’ AQUABEAM System, in large prostates (80 mL to 150 mL) for the treatment of BPH. The study will enroll 100 patients at up to 20 sites in the U.S. and Canada, with patient follow-up out to 12 months. The WATER II Study is a follow-up study to the successful WATER Study, which showed a superior safety profile for Aquablation with very strong efficacy outcomes comparable to transurethral resection of the prostate for the treatment of BPH in prostates 30 mL to 80 mL, according to PROCEPT BioRobotics.
Urinary incontinence agent’s new drug application accepted by FDA
Following the launch of the phase II clinical study of its leading compound Litoxetine IXA-001 in Europe and Canada, Ixaltis has announced the FDA’s acceptance FDA of the company’s investigational new drug application. The open application will allow Ixaltis to conduct a clinical study in the U.S. with the objective of assessing the safety, tolerability, and efficacy of Litoxetine as treatment for men and women suffering from mixed urinary incontinence, according to the company.
PCa treatment improves metastasis-free survival in phase III trial
The phase III PROSPER trial evaluating enzalutamide (XTANDI) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic castration-resistant prostate cancer (CRPC) met its primary endpoint of improved metastasis-free survival, Pfizer Inc. and Astellas Pharma Inc. recently announced. The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of enzalutamide in previous clinical trials. Based on the results of PROSPER, the companies intend to discuss the data with global health authorities to potentially support expanding the label for enzalutamide to cover all patients with CRPC.
Patents available for external urine collection catheter
ASG Services Inc. announced the availability of two U.S. and international patents for the manufacture and global sale and distribution of Ur24, an external urine collection catheter. The system’s Human Apparatus attaches to the urethra and is made of a medical-grade, pliable silicone gel and when attached to the urethra, urine can be directed to flow into a collection container that is part of the Urine Collection Apparatus. A combination of one-way valves known as the “breather” allows air into the Human Apparatus, and a low-pressure vacuum then directs the urine to flow into the awaiting Urine Collection Apparatus container, according to AGS Services. Ur24 will be a Class II FDA product that will not require clinical trials, the company said.
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