Good News for Kianna

The WSJ Ed Page reports progress in the FDA:

Cancer victims got some holiday cheer Tuesday when the Food and Drug Administration approved Bayer's Nexavar for the treatment of advanced kidney cancer. Nexavar is the first new treatment for this particularly deadly cancer to be approved in more than a decade. And it's an easily administered pill that produces minimal side effects compared with chemotherapy.

Nexavar also happens to be one of the two promising developmental drugs we highlighted earlier this year in editorials on the plight of Kianna Karnes, who died in March, unable to obtain either of them for treatment. Tuesday's approval by no means makes full amends for that scandal. But it does show that the FDA is finally taking seriously complaints about tardiness, and at least acknowledging the ethical issues involved in giving people placebos (i.e., sugar pills) when testing drugs for terminal disease.

On the rapidity front, the important news is that the Nexavar approval was granted based on a new way of measuring the effectiveness of cancer therapies. Until now, believe it or not, the FDA's cancer division has usually focused on crude mortality statistics when approving new drugs and scoffed at other possible metrics such as tumor shrinkage and improved quality of life. But in conjunction with the American Society of Clinical Oncologists, the FDA has recently decided to recognize "progression-free survival" -- no tumor growth or metastasis, and no death -- as a sufficient clinical benefit.

To put it plainly, the FDA is no longer insisting that we wait around for people to die to get statistics when a drug is obviously working. This should enable faster approval of other drugs in the future. Nexavar, by the way, doubles the length of progression-free survival in advanced kidney cancer.

I blogged about Kianna's Law last March, and Senator Brownback from Kansas is still pursuing it. Miles to go, but much good news for the season.

MERRY CHRISTMAS, Y'ALL!

Pharmaceuticals Posted by jk at December 23, 2005 1:12 PM