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.
EV/pembrolizumab under review in China for advanced urothelial carcinoma
March 28th 2024The sBLA is supported by findings from the phase 3 EV-302 trial, which showed that EV/pembrolizumab extended overall survival and progression-free survival vs platinum-based chemotherapy in patients with advanced urothelial carcinoma.
Potential code for prior authorizations on AMA CPT Editorial Panel meeting agenda
March 28th 2024"Good public and economic policy must align costs, benefits, and incentives; currently, all costs are incurred by physician practices, and all financial savings and benefits from prior authorization accrue to health insurance plans, leading to perverse incentives,” says Alex Shteynshlyuger, MD.