Twelve Days

There's nothing quite so depressing as a day spent with the Food and Drug Administration's Oncologic Drugs Advisory Committee. On Tuesday, ODAC, as it is fondly called by its denizens, approved a new drug for pancreatic cancer that extended patients' lives by an average of 12 days while subjecting them to sometimes fatal side effects.

But don't think the ODAC is without standards. The 10-2 vote in favor of OSI Pharmaceutical's Tarseva came right after the committee unanimously rejected Abbott Lab's prostate cancer drug. Xinlay, as it is known, failed to extend life at all.

Thirty five years into the war on cancer, here's where we're at on pancreatic cancer. If you get it, you're a dead man walking. Take the best chemotherapy drug now on the market, Gemzar by Eli Lilly, and you'll live an average of 5.95 months. Add OSI Pharmaceuticals' newly recommended Tarseva to the mix and you've got 6.37 months. I'll do the math for you. It's about 12 days. The FDA usually follows the advice of its advisory committees.

Of course, the dying patients on Tarseva will have to put up with severe diarrhea, various other complications and an increased risk of stroke. Indeed, seven percent of several hundred patients in the trial on the new drug died of those complications, compared to none from Gemzar alone. By the way, no patients in either arm survived the trial, which lasted less than two years.

Clearly, Gemzar was no great breakthrough either. When it was approved in 1996, it increased the median lifespan of its trial enrollees from 4.2 months to 5.7 months. Put these two new drugs together and the cancer industry has added an average of two pain-wracked, chemo-tortured months to patients lives.

Abbott Labs, meanwhile, showed it obstinacy by even bringing its drug to ODAC. Its own data monitoring committee had ordered the trial stopped midstream when it became clear that no one was benefiting from the drug. But Xinlay had an intriguing scientific concept pushing it forward (the academic researcher who discovered the mechanism also conducted the clinical trial). Once prostate cancer spreads to surrounding bones, it triggers out-of-control bone deposits, which causes the unbearable pain of end stage prostate cancer (95 percent of patients spend their last days on opiates).

Xinlay was designed to interfere with the bone deposition process. And apparently it worked if all you considered were pictures of patients' bones. Unfortunately, no ones life was extended by taking the drug. And the FDA reviewers said the differences in reported pain among patients on the drug versus those not on it were minor and suspect because it was based on a subjective survey. All the patients knew they were on the drug.

So, I'm afraid I must report there was not much good news for people struck by these two major killers (most of the prostate cancer patients were 70 or older, but over half of the pancreatic cancer patients, evenly divided between men and women, were under 65). But it was good news for OSI. The company expects sales of $150 million a year within a few years.

Meanwhile, thalidomide's comeback continued today when ODAC approved Celgene's Revlimid, which is a chemical cousin to the once notorious drug. The new drug will be used against a mild form of leukemia called myelodysplastic syndrome.

This disease requires a blood transfusion about every month. But by taking Revlimid, about two-thirds of these patients became transfusion free for an average of 7 months. Celgene anticipates at least $500 million a year in sales and perhaps three times that amount if doctors begin using it for more serious forms of the leukemia.

That sounds like a pretty good deal: take an oral drug to stay off transfusions for more than half a year. But Dr. Richard Pazdur, head of the FDA's oncology branch, warned the company that it would have to make sure pregnant women didn't take the drug. Thalidomide, sold in Europe in the late 1950s to ward off morning sickness in pregnant women, caused severe birth defects in their unborn children.

Posted by gooznews at September 14, 2005 10:34 PM