Will FDA's ODAC Give PegIntron® A Green Light, Tomorrow?

UPDATED -- 10.05.09 @ 11:00 AM EDT: ODAC splits, but ultimately votes 6 to 4 -- in favor of approval. Dr. William Kelly of Yale University's School of Medicine dissents, saying "I voted no because I think survival has to be the primary endpoint here. . . ."

So, in cancer patients, with only a very small (very short duration) survival benefit, and a rather serious side-effect profile, will the FDA's Oncologic Drug Advisory Committee -- at its meeting tomorrow morning -- nevertheless recommend that the full FDA approve Schering-Plough/Merck's PegIntron^®?

Who knows? [You can pay $140 to watch the ODAC meeting, in real time, though.] Quoting form the FDA ODAC background materials, now (at Page 17 of the PDF -- image at right, is derived from Page 18):

. . . .The final analysis of overall survival was to be conducted after 486 deaths; however as of the data cut-off date of March 31, 2006, a total of 525 deaths. There was no difference in overall survival between the peginterferon alfa-2b and the observation arms. The estimated hazard ratio for overall survival comparing the Peg-IFN alfa-2b arm to the observation arm was 0.98 (95% CI: 0.82-1.16). . . .

So, any given cancer patient on the studies' medications had only a 2 in 100 chance of seeing a statistically-significant survival benefit (and even then, it might only be a few months). Click on the image (at right) to enlarge it. We'll report, once the result of the ODAC meeting is known.