NDA submitted for agent that targets metastatic prostate Ca
Centocor Ortho Biotech Inc. has submitted a new drug application to the FDA for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane.
Centocor Ortho Biotech Inc. has submitted a new drug application to the FDA for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane.
The application follows completion of a phase III, randomized, double-blind, placebo-controlled clinical study, which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone plus prednisone compared with treatment with placebo plus prednisone. Data from this multicenter study, which included 1,195 patients from 13 countries, were presented at the 2010 European Society for Medical Oncology annual congress in Milan, Italy. (For details on these study findings, see http://www.urologytimes.com/abirateronedata.)
If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies outside the U.S.
AUA, SUFU publish 2024 guideline for idiopathic overactive bladder
April 25th 2024“This brand new guideline offers options for all patients with OAB with a focus on shared decision-making between patients with OAB and clinicians, as well as a personalized, tailored approach to care,” said Cameron and Smith.
Enzalutamide granted approval in EU for nmHSPC
April 24th 2024The approval is supported by data from the phase 3 EMBARK trial, which demonstrated that enzalutamide with or without leuprolide prolonged metastasis-free survival compared with leuprolide alone in patients with high-risk biochemically recurrent nmHSPC.
