US oncology specialist Dendreon Corp has received a positive recommendation from a US regulatory panel for its prostate cancer treatment Provenge.
The US Food and Drug Administration’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the agency that there is “substantial evidence of efficacy and safety” of Provenge (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent prostate cancer and a final decision is expected by May 15.
Dendreon noted that the panel voted 17-0 in favour of the safety of the drug and 13 to 4 for its efficacy and if approved for marketing by the FDA, Provenge will become the first active cellular immunotherapy and the first biologic to be approved to treat prostate cancer. Data from two randomised, double blind, placebo-controlled studies were submitted and both studies failed to meet their primary endpoints, ie slowing progression of the disease. However in the first 127-patient trial, the median overall survival in subjects treated with APC8015 was 25.9 months, compared to 21.4 months among placebo subjects, while the second study, of 98 patients, only showed a trend toward improvement in overall survival.
Dendreon’s shares have soared in the last week while investors waited for the FDA panel’s decision and if approval does come, despite the less-than-convincing data, Provenge would be the company's first approved product and could generate as much as $1 billion a year.