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Breakthrough Cancer Pill Wins Marketing Approval

Aired May 10, 2001 - 13:34   ET


LOU WATERS, CNN ANCHOR: Let's bring in our medical reporter Rhonda Rowland, who has been working this story for quite some time. This is something that began happening about three years ago.

RHONDA ROWLAND, CNN MEDICAL CORRESPONDENT: Right, that's three years ago, we first reported this when they saw astounding results in just 31 patients. They found that it actually worked in all 31, which was totally amazing in a drug that was just being looked for its safety profile, that they saw that it worked.

And ever since then, the trials have expanded. It's continued to do well. They have seen in patients, who have taken the drug for about a year, that a large percentage has actually gone into remission. Quite amazing, quite amazing; it's called Gleevec.


TOMMY THOMPSON, SECRETARY OF HEALTH & HUMAN SERVICES: ...excited I am and pleased with the announcement that we're going to have today. And so many wonderful people have been involved in this thing, making this day possible. I can't mention every one of them, because we would spend the whole afternoon just recalling all of the heroic efforts that everybody did.

But I do want to personally thank all of these people in the first two rows, who were individuals who supervised and finally gave the approval to the drug. And I can't tell you, as secretary of this department, how proud I am, of each and every one of you, and what you have been able to do. We are truly in your debt.

I come from a family that lost three close members to cancer. So any time that you have a breakthrough, it is a really a red-letter day. And today, I have the privilege of announcing one of those medical breakthroughs, which, to me, is outstanding. And like most scientific breakthroughs, this one is not sudden, nor does it stand alone -- rather, like most scientific advancement, is the culmination of years of work and years of investment by many people in many different institutions, and even in different fields of medicine.

And it's a collaboration of government, scientists, private companies and students and individual patients that have made this possible. And I can't tell you how pleased I am to have the head of Novartis here, who flew in and arrived at 2:00 this morning. And it was one of his predecessor's companies Ciba Geigy from Switzerland, that started us down this road by discovering the molecule that Dr. Druker from Oregon proceeded to find a way to put into a medicine.

And Dan, thank you very much for coming and flying over here. To a patient that has been taken the medicine for a year, you'll be hearing from both of these individuals. And of course, Bernie Schwetz, who is the acting head of the Food and Drug Administration, that had to approve and look at the clinical trials, and to make sure that everything was correct. To me, one of the really outstanding scientists in America today.

Dr. Rick Klausner, who is the head of the Cancer Institute, who told me about this some three weeks ago, and I can't tell you how pleased and honored I am to be on the stage with these wonderful people.

We're here to announce one dramatic product of all of these efforts. But we believe many more products will follow, based on the years of scientific groundwork that's already taken place. So this is the right time to acknowledge those efforts, and to recognize that our investments and research are finally paying off big time, and to praise the teamwork that has brought us here.

It's also the right time to talk about what this can mean for our future. And so many wonderful people are part of that -- a future that promises a new level of precision and power in many of our pharmaceutical products.

Today, the Food and Drug Administration has approved this morning a new drug called Gleevec for the treatment of chronic myeloid leukemia or commonly referred to as CML. You are going to hear more about this drug later.

But let me just say that it appears to change the odds dramatically for patients. And what a wonderful thing to say. And it does so with relatively low occurrences of serious side events. A mild nausea is about all that you can anticipate. It's because this drug has been engineered in the laboratory to target a single cancer- causing protein and, like a light switch, turn off its signal to produce leukemia cells. It's designed to kill leukemia cells, while leaving the normal white blood cells alone.

And as Rick Klausner explained to me, it's like having somebody put their foot on the accelerator and have it down to the floor on your car, which produces the protein that this drug pulls the foot feed, or the accelerator, back, and stops producing the protein.

If this does not sound like the same arduous chemotherapy regimen that one of your friends or loved ones have received in years past, that's because it is not. This oral drug is based on the concept of molecular targeting. And we believe such targeting is the wave of the future. A wave of scientific progress in which researchers like Rick find the bad circuits buried inside of a tumor cell. They craft the drug in the laboratory to shut off its erroneous cancer-causing signal. Then they deliver the drug directly to the cancer cells, leaving the healthy cells alone.

Today, we celebrate Gleevec. But we also have good reason to think that there maybe other Gleevecs under development in our nation's laboratories, medical centers, and drug companies. We need to do all that we can to develop these drugs and get them to the people waging their own personal battles against cancer, like Suzanne (ph).

I also want to highlight this new cancer drug, because it epitomizes the type of scientific research that is taking place in America today, and the public as well in the private sectors. And that's why such a glorious afternoon because all of them are represented up here, and we can bring them together for this great announcement.

We are on the cusp of so many breakthroughs in ways to treat diseases that were previously untreatable, or at least untreatable without painful side effects, and uncertain results. We're on the path to finding cures to diseases that have longed plagued humans, such as leukemia, and other cancers. This breakthrough underscores the importance of continued investment and research in this country.

The president is giving research the highest of priorities in his administration. And I have to admit that it's a bipartisan cause, and it rightly should be. The president believes so much, and passionately, in the power of research. He understands that the payoff for scientific investment like today stands to be tremendous for the health and the quality of health of millions of Americans and, in this case, millions of people worldwide.

And here at HHS, throughout all of our agencies, we are committed to aggressively pursuing the medicines and the scientific discoveries that will help us all better tackle hideous diseases and improve the quality of health for our citizens. Scientists and government, academia and in industry, have been laying the foundation for molecular targeting for several years. They've recognized that it represents an exciting and promising approach in cancer research.

And speaking for the president, and the scientists in my department, especially at the National Cancer Institute, I know that none of them will let up in the future.

The truth is that we are here today because of teamwork, partnership, and collaboration. I cannot overemphasize the importance of this point. Dr. Brian Druker of the Oregon Health Science University, and scientists at Novartis Pharmaceuticals and those people in the clinical trials at MD Anderson and Texas and those at UCLA Hospital, and people at the National Cancer Institute have worked in tandem to bring Gleevec to the market. They have done a remarkable job, and joining in the long-term efforts, have been many colleagues, from other medical centers, such as MD Anderson and UCLA, as well as the NCI.

The Food and Drug Administration has also contributed to this remarkable project by awarding Gleevec the status of an orphan drug, to add incentive to its development, and by reviewing Gleevec in just 2 1/2 months. That is an all-time record for a cancer drug and for the evaluation of a highly-complex novel drug. Today, Gleevec arrives as a remarkable new medicine for people with CML. It arrives as a proof of principle from molecular targeting and cancer care. It arrives based on a firm foundation of research investment, a foundation we intend to continue nourishing. And it arrives as a testament to the can-do attitude and the will of our nation's scientific community. There's a lot to celebrate and a tall order for continued progress in the future.

And now, it is my tremendous delight to introduce the acting secretary of the Food And Drug Administration.

ALLEN: You can tell the Health and Human Services Tommy Thompson is very enthusiastic about this announcement today.

ROWLAND: He is indeed. And he has good reason to be.

WATERS: "Big time," ventures and research are paying off, he says.

ROWLAND: That's right.

WATERS: And paying off quickly.

ROWLAND: Quickly. He's hailing this as a breakthrough, calling Gleevec one dramatic product. And this drug, once it was first tried in a human -- that was less than three years ago, and now it's approved -- is possibly setting a record for an FDA approval.



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