By ANDREW POLLACK
The first therapy that would direct a cancer patient’s own immune system to attack tumors moved a step closer to approval yesterday when it was endorsed by a federal advisory committee.
The advisory panel to the Food and Drug Administration voted 13 to 4 that there was “substantial evidence” that the treatment was effective in men with advanced prostate cancer and 17 to 0 that the therapy was safe.
The votes increase the likelihood of F.D.A. approval for the therapy, Provenge, by the agency’s May deadline. Still, even panel members who voted for the drug expressed some reservations about the strength of the data. That could leave the door open for the agency to reject Provenge until a bigger trial, now under way, is completed in 2010.
Provenge was developed by Dendreon, a Seattle biotechnology company.
Approval of Provenge would open a new front in the war on cancer because its mode of action is different from that of existing drugs and radiation, which attack cancer cells directly. Provenge is a personalized therapy in which some of a patient’s white blood cells are removed, processed by Dendreon, then infused back into the body three or four days later.
Approval would also represent the first success after numerous setbacks in efforts to develop what are sometimes called cancer vaccines, not because they prevent cancer but because they harness the immune system to fight the disease after it develops.
“The positive recommendation from the advisory panel is an important step in the development of cancer vaccines,” said Dr. Lloyd J. Old, chairman of the Ludwig Institute for Cancer Research in New York, who has long worked on such vaccines. Dr. Old called the vote encouraging to a field that has “generated disappointment and controversy in the past.”
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