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CNN Live Sunday

FDA Gives Gleevec Green Light, Many Call it a 'Breakthrough'

Aired May 13, 2001 - 16:08   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DONNA KELLEY, CNN ANCHOR: A new drug approved for an adult form of leukemia is showing great promise in treating a type of stomach cancer. As well, the U.S. Food and Drug Administration gave the medication a green light last week. It's hailed as a major breakthrough; the pill is taken once a day, causes virtually no side effects. CNN's medical correspondent Rhonda Rowland with our report.

(BEGIN VIDEOTAPE)

RHONDA ROWLAND, CNN CORRESPONDENT (voice-over): To look at 41- year-old Marina Symcox today, it's hard to believe last fall she was preparing for her funeral. She had given up on cancer treatment, and signed out for hospice care. She was on narcotics and bed-ridden.

MARINA SYMCOX: I can remember my mom coming upstairs and just stroking my hair and saying, I'm so sorry things have turned out this way for you.

ROWLAND: At age 38, she was diagnosed with gastrointestinal stromal tumor, or GIST, a type of stomach cancer that affects as many as 5,000 Americans each year. Until now, there was no effective treatment for GIST.

SYMCOX: I had absolutely been given no hope right from the beginning.

ROWLAND: Through the Internet, her husband found out about a study of the cancer pill Gleevec. Researchers had already seen amazing results with the pill, in a type of leukemia.

DR. CHARLES BLANKE, OREGON HEALTH SCIENCES: It turns out that the GIST or gastrointestinal stromal tumors, have a target that is very closely related, and it also drives their malignant behavior.

ROWLAND: Unlike traditional chemotherapy, which attacks all cells randomly, this drug blocks action of an enzyme that causes GIST, leaving healthy cells untouched. The pill, taken just once a day, has virtually no side effects. As was the case with leukemia, researchers often saw results in GIST patients within days.

BLANKE: We were very shocked, but highly, highly encouraged.

ROWLAND: A study of 148 GIST patients shows 59 percent went into remission. The result even better in those with the most common type of mutation. A second smaller study had similar results.

(on camera): Because Gleevec has been approved for the treatment of chronic mylogenous leukemia, and since studies show the pill also works in GIST, theoretically, doctors could prescribe the pill off label for treating GIST.

DR. HAMON EYRE, AMERICAN CANCER SOCIETY: Giving it to patients with gastrointestinal tumors or other kinds of cancers that might work would be a reasonable situation, if it was done with full knowledge of the patient and the doctor.

ROWLAND: Doctors say Marina Symcox's cancer is in remission. She wanted to live long enough for her children to know and remember her. She got her wish.

SYMCOX: My gosh, we have a family life which we didn't have before. We were the town tragedy. Truly. It's just a big miracle.

(END VIDEOTAPE)

ROWLAND: So even though doctors can go ahead and prescribe Gleevec for patients with gastrointestinal stromal tumor, researchers are encouraging patients to get involved in studies, because they still need more information on which patients do best with this, how they do long term, and also the kinds of side effects they can expect to suffer.

But Donna, what's so exiting here is that researchers can now say that with this one pill, they are putting patients with two kinds of cancer into remission, both the leukemia and this kind of stomach cancer.

KELLEY: Isn't that interesting, that they would be such two different kinds of cancer. Do they have an idea why it's working on two different kinds of cancer like that?

ROWLAND: They do with these particular types, because the molecular mechanism that actually drives both of these cancers are very similar. So this drug goes in and blocks the action of this particular enzyme. Even though they are different, they are still similar.

But Donna, that doesn't mean it will work for other kinds of cancers as well.

KELLEY: That's my next question. If it was going to do for two, why wouldn't it go further and maybe be for others?

ROWLAND: They are doing some studies to see how many cancers can be helpful. And since right now, there's a study in a type of brain tumor, also lung and prostrate cancer, with Gleevec.

Now, even if Gleevec does not work in these particular cancers, they believe that perhaps they can come up other kinds of medications that are similar to Gleevec that could work in other cancers. And in fact, the researchers are so optimistic that eventually, as they discover the molecular mechanisms that cause each and every kind of cancer, they can come up with drugs for each and every type. So, all will eventually be helped in the same way.

KELLEY: Boy, it seems like there's a lot of really exciting cancer news coming out with some of these newer drugs. What about the side effects?

ROWLAND: Well, with this particular one, what is so interesting is there are virtually no side effects. With Marina Symcox, the woman we talked to in this particular story, she was ill the first month she took the pill.

She had a lot of gastrointestinal upset, but now, she's said she has virtually no side effects, maybe just a little diarrhea. Some patients have a little bit of muscle aches, a little bit of swelling. But that's really it, Donna.

And that's really quite astounding when you compare that to traditional chemotherapy, where people get so ill. So, that's why it's so amazing and so encouraging.

KELLEY: Let's hope. It certainly is exciting at this point. Rhonda Rowland, thanks very much.

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