Provenge: The Battle for a New Prostate Cancer Treatment
Right now, there is a public drama being played out between the FDA and a company called Dendreon, whose product Provenge is being developed for treatment of prostate cancer. What distinguishes this particular drug approval process is the public nature of the debate, with strongly worded statements from advocates and investors who each have large stakes -- though not necessarily the same stakes -- in the ultimate outcome of the FDA decision.
Before a drug can be sold in the US, it must be approved by the Food and Drug Administration (FDA) as being safe and effective for its stated purpose. As you might imagine, the stakes for a company seeking drug approval are very high. The only hope for a return on their investment in the drug is the ultimate approval, which allows them to market the product.
The FDA approval process begins at the time before major studies are conducted on a drug. The manufacturer will often meet with the FDA, and lay out a series of clinical trials and goals to be met for approval. Usually in cancer medicine, the company and the FDA will negotiate a particular endpoints such as time before tumor progression, or percentage of responses in patients with advanced cancer, or improvement in overall survival. In general, if the subsequent clinical trial meets those endpoints, FDA would consider granting approval.
However, there are additional layers to the approval process. FDA conducts an internal review of the data and also appoints expert panels that advise FDA. Those panel recommendations may, or may not, be honored in final FDA deliberations.
Sometimes the discussions get very complicated and intense. For instance, studies might meet some endpoints (like improving the length of tumor control), but not others (like improving overall survival). In other cases, side effects might emerge which undermine the anticipated safety of the drugs.
FDA, like many regulatory agencies, is relatively short-staffed, and must confront requests from innumerable parties such as drug manufacturers, advisory panels, patient advocates, and others in reaching their conclusions.
Here are several recent newspaper stories on this battle. It will be interesting to see what happens.
Do you think the FDA is right to study this drug further before approving it, or should experimental cancer therapies be fast-tracked through the approval process?
Related Topics:
Technorati Tags: provenge, dendreon, FDA, prostate cancer, vaccine
Before a drug can be sold in the US, it must be approved by the Food and Drug Administration (FDA) as being safe and effective for its stated purpose. As you might imagine, the stakes for a company seeking drug approval are very high. The only hope for a return on their investment in the drug is the ultimate approval, which allows them to market the product.
The FDA approval process begins at the time before major studies are conducted on a drug. The manufacturer will often meet with the FDA, and lay out a series of clinical trials and goals to be met for approval. Usually in cancer medicine, the company and the FDA will negotiate a particular endpoints such as time before tumor progression, or percentage of responses in patients with advanced cancer, or improvement in overall survival. In general, if the subsequent clinical trial meets those endpoints, FDA would consider granting approval.
However, there are additional layers to the approval process. FDA conducts an internal review of the data and also appoints expert panels that advise FDA. Those panel recommendations may, or may not, be honored in final FDA deliberations.
Sometimes the discussions get very complicated and intense. For instance, studies might meet some endpoints (like improving the length of tumor control), but not others (like improving overall survival). In other cases, side effects might emerge which undermine the anticipated safety of the drugs.
FDA, like many regulatory agencies, is relatively short-staffed, and must confront requests from innumerable parties such as drug manufacturers, advisory panels, patient advocates, and others in reaching their conclusions.
Here are several recent newspaper stories on this battle. It will be interesting to see what happens.
- Seattle Times: FDA Sued over Provenge Delay
- Washington Post: FDA Delay in Cancer Therapy is Attacked
- Boston.com: Prostate Therapy's Delay Sets Off a Fight
Do you think the FDA is right to study this drug further before approving it, or should experimental cancer therapies be fast-tracked through the approval process?
Related Topics:
Technorati Tags: provenge, dendreon, FDA, prostate cancer, vaccine
