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.
GU cancer diagnoses may have adverse health impacts for patients’ family members
September 12th 2024“As health care professionals, we should take a multidisciplinary approach to addressing the stress of a cancer diagnosis by helping mitigate financial toxicity, treatment burden, and emotional impact on both the patient and their family," says Mouneeb M. Choudry, MD.