Gleevec Given Priority FDA Review for Intestinal Cancer
The U.S. Food and Drug Administration has given priority review to the Novartis drug Gleevec (imatinib mesylate) as a treatment for gastrointestinal cancer after surgery, the Associated Press reported Wednesday.
Priority review means the agency is likely to decide whether to approve Gleevec for gastrointestinal stromal tumors within six months, instead of the typical 10 months. The drug is already approved to treat other types of cancer.
Novartis said in clinical testing, people with kit-positive gastrointestinal cancer who got Gleevec lived longer and were 89 percent less likely to have the cancer return than those who didn't take the drug, the wire service reported.
A protein mutation that characterizes kit-positive forms of this cancer is present in more than 90 percent of cases in the United States, the AP said.
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TV Ad Condemns the Hot Dog
A television ad that links eating hot dogs with colon cancer doesn't exactly cut the mustard, critics charge.
"I was dumbfounded when the doctor told me I have late-stage colon cancer," mourns a little boy in the 33-second ad, according to the Associated Press. But in truth, the boy and two hot-dog-eating co-stars don't have the disease, the AP added.
The ad is sponsored by a group with vegetarian ties called The Cancer Project. Its president, Dr. Neal Barnard, defends the video as "a way to raise appropriate concern about a deadly concern."
The ad is premised on a November 2007 study that found eating 50 grams per day of processed meats over several years increases the eater's risk of colon cancer by 21 percent. That works out to about one hot dog per day, or two slices of bologna, or five slices of bacon each day, the AP said.
The ad's sponsor wants processed meats banished from school lunch menus nationwide. But critics say the video goes too far.
"My concern about the campaign is it's giving the indication that the occasional hot dog in the school lunch is going to increase cancer risk," the wire service quotes the American Cancer Society's nutrition director, Colleen Doyle, as saying. "An occasional hot dog isn't going to increase that risk."
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Vaccine Said to Ward Off Bird Flu
An experimental bird flu vaccine appears to generate an immune response in people that can help guard against getting the disease, its producer says.
The deadly H5N1 strain of bird flu has killed more than 240 people since 2003, mostly in Asia. Experts worry that it will mutate to a form that's more easily passed from birds to people, triggering a human pandemic.
Novavax Inc. said of 160 people who got its two-injection vaccine, 94 percent produced an immune response against the virus, the Bloomberg news service reported.
The company's process uses insect-cell cultures, allowing it to produce seven to 10 times as much vaccine in the same span as older techniques that rely on mammal eggs or cells.
Traditional vaccines are made from chicken eggs, a process that can take up to six months. Novavax, by contrast, said it can produce a vaccine within 12 weeks of identifying a bird flu strain, Bloomberg reported.
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Parkinson's Drug Slows Disease Symptoms: Maker
A drug already approved by the U.S. Food and Drug Administration is the first medication to demonstrate that it hinders the progression of Parkinson's disease, the Bloomberg news service quotes the Israeli drug maker Teva Pharmaceuticals as saying.
Azilect slows the body's production of an enzyme that destroys dopamine, a hormone that when in short supply causes the tremors, depression, speaking and movement problems that characterize Parkinson's, the news service said.
In presenting clinical data at a medical conference in Madrid, Teva issued a statement saying Azilect demonstrated "significant improvement" in people who had taken the drug for 18 months, compared with those who had taken it for nine months.
Teva plans to ask the FDA for permission to label Azilect as a way to slow the progressive symptoms of Parkinson's, Bloomberg said.
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FDA Raises Concern About New Ovarian Cancer Test
The U.S. Food and Drug Administration says it is alarmed about a new blood test that its distributor says can detect ovarian cancer in its early stages, The New York Times reported Tuesday.
OvaSure, developed at Yale University, has been offered for about two months by one of the largest U.S. clinical laboratory firms, LabCorp. Despite an overwhelming need for such a test, the FDA and some medical organizations have raised red flags since its introduction in June, saying the diagnostic hasn't been tested enough, the Times said.
The Society for Gynecologic Oncologists almost immediately issued a statement, saying the organization feared unnecessary operations spurred by false positives.
If ovarian cancer is detected before it spreads from the ovaries, more than 90 percent of women in this stage will survive at least five years, the newspaper reported, citing the American Cancer Society.
Nonetheless, the FDA, which generally doesn't regulate diagnostics performed by a single laboratory, has informed LabCorp that there doesn't appear to be enough clinical data to validate that the test actually works, the Times reported.
In an Aug. 7 letter to LabCorp posted on the agency's Web site, the FDA said, "We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health."
LabCorp responded that it looked forward to discussing the test with the agency, adding that it would continue to offer the diagnostic in the meantime, the newspaper said. The test costs $220 to $240.
The American Cancer Society estimates more than 21,000 cases of ovarian cancer will be diagnosed in the United States this year, and more than 15,000 are expected to die from the disease, the Times reported.
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