FDA Approves Tarceva for Expanded Use

Ever since they suspended the clinical trial of the maintenance drug I was on, I have worried that am doing nothing to proactively prevent a recurrence. I feel like I am just waiting around for cancer to strike again. It makes me uncomfortable and anxious. I would rather take the fight to the enemy than do nothing. So I have been reading up on things I can do on my own.

One of the best things I can do is fight this disease with nutrition. Everything that I have been reading has led me to believe that the key to cancer-free health is good nutrition. Fruits and vegetables that are high in antioxidants are known to be beneficial. I am drinking POM Wonderful (pomegranate juice) nearly every day.

I was approached by one multi level marketer recently who recommended a drink called Xango, which is made from the mangosteen fruit. I tried a complementary bottle. It is better tasting than Mona Vie, which is made out of the acai berry, but I think they are in the same class of product – high priced juice drinks with potential (although unproven) health benefits. (I think I’d be just as well off with low-priced fruit juice concentrates from Publix.)

I’ve been complaining about our Food and Drug Administration for some weeks now because I don’t see them doing anything useful, (except creating roadblocks and obstacles to cancer research and fretting about innocuous fruit drinks that may actually be helpful.)

As they did for POM Wonderful, the FDA did put out warning letters to the makers of both Xango and Mona Vie to not make medical claims about their products in their advertising. But does that mean these drinks don’t have any medicinal benefit? No. What I think it means is that they don’t have any measured benefits meeting the FDAs scientific standards for a “drug.”

This is the same FDA that recently approved the chemotherapy drug Tarceva (erlotinib) as maintenance therapy for patients with locally advanced metastatic lung cancer, despite a nearly unanimous (11-1) vote AGAINST expanded use of the drug by the FDA’s own panel of experts who examined the evidence.

Why do you think the powers that be in the FDA overruled its own experts?

In the SATURN trial, nearly 900 patients with advanced non-small cell lung cancer received four cycles of first-line platinum-based chemotherapy. Patients were then split into two groups: one received placebo, and the other received maintenance Tarceva.

For patients on Tarceva, median progression-free survival (the time before the cancer progressed) reached 12.3 weeks, compared with 11.1 weeks for patients taking placebo. The Tarceva group lived only slightly longer, with median overall survival reaching 12 months for patients on Tarceva versus 11 months for those on placebo.

Sounds to me like Tarceva as a “maintenance drug” has as much benefit as POM Wonderful, Xango, or Mona Vie. Only Tarceva costs around $2000 per month, about 20 times more than high-priced medicinal juice!

Until now Tarceva has been limited to use for advanced lung cancer that grew or spread after first line chemotherapy. Tarceva, an oral drug, is known to work well for those people who have the EGFR (epidermal growth factor receptor) gene mutation, which is only about 10% of lung cancer patients with non-small cell lung cancer.

At the National Lung Cancer Advocate Summit a few weeks ago, some of us fighting for lung cancer research were dumfounded that the FDA would approve expanded use of Tarceva for maintenance therapy when we know that it does NOT work for most lung cancer patients.
OSI Pharmaceuticals, the maker of Tarceva, is surely pleased to now have approval to market their drug to a much larger universe of patients. It won’t be long before we see TV commercials for the approved use, no doubt, urging lung cancer patients to “ask your doctor about Tarceva.” It’s an abomination.