Would FDA Reform Speed Cancer Vaccines?
November 26, 2002
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But not one is close to market yet, and the Food and Drug Administration's (FDA's) outdated approval procedures aren't helping, says the Wall Street Journal.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 statistical significance of the data overall.
Since the FDA doesn't allow researchers to identify a target group retrospectively when they submit a study for approval, Dendreon now has to complete a study targeting patients with lower Gleason scores.
Many new treatments under development will work for certain subgroups of cancer patients which are unknowable in advance. The Journal argues, "Why not allow companies to cull the relevant data from existing studies when a certain subgroup is clearly helped?"
And "Why not make it easier to test these drugs as front-line treatments in combination with standard therapies, perhaps by granting conditional approvals and collecting data from actual clinical practice? The FDA did this successfully with AIDS drugs, but has been skittish about applying that approval model to cancer."
Source: Editorial, "Now for the Real Cancer Vaccines," Wall Street Journal, November 26, 2002.
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