Would FDA Reform Speed Cancer Vaccines?
Merck, a pharmaceutical company, has produced a vaccine for the human papilloma virus that appears effective in preventing cervical cancer, and products are currently being developed to treat many other cancers, including melanoma, breast and lung. But not one is close to market yet, and the Food and Drug Administration’s (FDA’s) outdated approval procedures aren’t helping, says the Wall Street Journal. • For example, in August Seattle-based Dendreon completed a placebo-controlled Phase III trial of Provenge, a prostate cancer vaccine, involving 127 late-stage patients whose cancer had spread and for whom the standard treatments of surgery, radiation and hormone therapy had failed. • In patients with Gleason scores (the standard measure of tumor aggressiveness) of seven or lower, those receiving Provenge were eight times as likely to go six months without disease progression as the placebo group. • But the inclusion of patients with Gleason scores of seven or higher reduced the statist