Avastin approved by FDA despite toxic side effects
It’s making news headlines — The FDA’s Oncologic Drugs Advisory Committee just approved the drug by biotech powerhouse Genentech for use in conjunction with chemotherapy to treat metastatic breast cancer.
Research has shown that use of the drug in combination with paclitaxel (Taxol) chemotherapy resulted in a 52 percent reduction in the risk of disease progression or death compared to those treated with paclitaxel alone — a doubling in progression-free survival.
From the Genentech press release: “There is no cure for metastatic breast cancer so it is important to control the disease as early and for as long as possible,” said Kathy Miller, M.D., Associate Professor of Medical Oncology, Indiana University School of Medicine and lead investigator on the E2100 trial. “Now with Avastin plus paclitaxel, we can increase the time a woman’s cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone.”
Without boring you with the specifics of how it works, I’ll share this: Avastin works by cutting off the blood supply to the tumors. That’s one way to kill those suckers — at long last.
Meanwhile, the toxic side effects of high blood pressure and well, death, were considered by some to be too problematic and perhaps should have deterred the FDA and inhibited their decision. But let me ask you this … if you have metastatic disease, aren’t you willing to take a risk to improve your chances of survival? Aren’t you facing death head on and deserving of anything that might help you void that apparently imminent collision? Isn’t this approval going to bring us one step closer to a cure for these people that need one the most?
Imagine you have a headache … but you couldn’t take Tylenol because it was never approved since you’d be at risk of contracting a headache if you take it. That’s hypothetical and I have no idea if headaches are a side effects of Tylenol — but I hope you get my point. The fact that metastatic patients are at risk of losing their lives every day seems to outweigh every other risk of fatality, I think.
Bravo to the FDA. Bravo to Genentech — this is right along with your mission to develop drugs to address significant unmet medical needs and you know patients with metastatic breast cancer have unmet needs!
More importantly, bravo to all of you out there with metastatic disease that might benefit from this new treatment option. Bring it on!
January 11th, 2010 at 5:57 am
While receiving chemotherapy for breast cancer and continuing to teach college level courses, a doctor friend of mine gave me Provigil (modifinal) a medication that encourages wakefulness. It was quite effective at treating chemo-brain and allowing me to continue to teach.
Since ending treatment, my cognitive functioning has returned to normal. I’m always saddened to realize how few doctors offer this sanity-saving medication to their patients going through chemotherapy.