FDA committee: Hormone-refractory PCa agent shows 'substantial evidence' of efficacy, safety
The FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of efficacy and safety of sipuleucel-T (Provenge) for patients with asymptomatic, metastatic hormone-refractory prostate cancer.
The FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of efficacy and safety of sipuleucel-T (Provenge) for patients with asymptomatic, metastatic hormone-refractory prostate cancer. If the FDA concurs with the committee’s report, sipuleucel-T would be the first active cellular immunotherapy and the first biologic approved to treat prostate cancer.
Dendreon Corp., manufacturer of sipuleucel-T, anticipates a decision by mid-May.
Dr. Chan on prevention, diagnosis, and treatment of kidney stones in pediatric patients
July 26th 2024"Stones that recur in children happen about 40% to 50% of the time. That's why the American Urological Association guidelines recommend doing a complete metabolic evaluation in all children," says Katherine Chan, MD, MPH.
Phase 1B trial to evaluate relugolix and enzalutamide in high-risk prostate cancer
July 24th 2024"Going forward after this study, we hope to be able to expand and potentially look at patients undergoing either surgery or radiation therapy, and really try to determine the potential benefit," says Kelly L. Stratton, MD, FACS.
