Pod Insights Short Wave Without this pill, lots of people would be dead About this episode 25 years ago, the FDA approved a pill that would change the way scientists treat cancer … for good. The pill was called Gleevec; it was designed specifically to treat CML, chronic myeloid leukemia, and it was one of the first targeted cancer therapies available. A quarter century after approval, it’s still being prescribed, as are second, third and fourth-generation drugs that followed in its footsteps. What made it so special – and so effective? Pharmaceutical correspondent Sydney Lupkin https://www.npr.org/people/825275572/sydney-lupkin walks us through the history of the drug, and why it’s continued to change lives for decades.
If you liked this episode, check out our other episodes with Sydney on accelerated drug approvals https://lnk.to/3hvV3G and the development of GLP-1 pills https://lnk.to/IkOvWA.
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Transcript Speaker names marked ? are inferred from speaking time and the show’s known hosts — they are not voice-verified.
0:00 Speaker 00 This message comes from Doppel. Social engineering attacks come in disguise, but Doppel sees through them. The Agentic platform shuts down threats, turns employees into first line defenders, and more. Learn more at D-O-P-P-E-L dot com.
0:16 Emily Kwong? You're listening to Short Wave from NPR.
0:22 Emily Kwong? Hey, Shortwavers. Emily Kwong here with NPR Pharmaceuticals correspondent Sydney Lupkin. Hello.
0:27 Speaker 02 Hi, Emily. So this weekend marked a very important anniversary.
0:32 Emily Kwong? Was it our anniversary? We have been friends for a long time.
0:35 Speaker 02 No.
0:36 Emily Kwong? Oh.
0:36 Speaker 02 Not our friendiversary, Emily. The anniversary of a pill that revolutionized cancer care.
0:41 Emily Kwong? Oh, that's way better. Not that I don't love you. Uh, what pill?
0:45 Speaker 02 So the drug is called Glivek, and May 10th marks 25 years since the Food and Drug Administration first approved it.
0:51 Emily Kwong? Okay. So Glivek, why is this pill such a big deal?
0:55 Speaker 02 Well, it's considered one of the first targeted cancer therapies. And what it really did was make some cancers that were once fatal not so fatal anymore, survivable.
1:06 Emily Kwong? Wow, that is a big deal.
1:07 Speaker 02 Yeah, and I talked about it with this guy in Atlanta. His name is Mel Mann. And he told me that in 1995, he was dealing with some back pain and fatigue, but it wasn't really clear why. Then, after an MRI showed what was going on with his bone marrow, he was diagnosed with chronic myeloid leukemia, a kind of blood cancer. He was 37 at the time and had a five-year-old daughter at home. The doctors told him he had three years to live.
1:34 Speaker 03 Yeah, I was shocked because, you know, that's the first time that I had to face my own mortality.
1:41 Speaker 02 But Emily, Mel is actually still here.
1:45 Emily Kwong? That is amazing. After being given only three years to live. So how, how did that happen?
1:50 Speaker 02 So after his diagnosis in January 1995, Mel starts doing bone marrow drives, hoping to find a match and get a lifesaving bone marrow transplant. Yeah. But at the time, if you were black, you had such a low chance of finding a match that he knew it was kind of an impossibility.
2:06 Speaker 03 And I would take my daughter with me. So she understood that I needed a match to live. In fact, one of the drives, she couldn't remember when, probably still five. She says, Daddy, I can't see why you can't find a match. All the blood looks the same to me.
2:26 Speaker 02 But after all this searching, Mel added thousands of people to the registry, but he didn't find a match for himself.
2:33 Speaker 03 Immediately, you're going to think of your family. And I thought, you know, how old she's going to be when, at the end of three years. And it was eight years. And I was trying to bargain for more.
2:46 Speaker 02 So he started participating in clinical trials for experimental treatments still in development. They would work for a few months and then stop. He outlived his expiration date, but wasn't doing well.
2:57 Speaker 03 By then, I was like really tired. I would sleep for eight hours, drink two cups of coffee, wake up and feel like I never went to bed. And we kind of like really lost a lot of weight. So I asked the doctor, were there any more drugs?
3:11 Speaker 02 And there was another one, Gleevec, though, of course, it was still being studied and didn't have that name yet. Mel started the drug in August of 1998. By the next June, Emily, he was running a marathon in Anchorage, Alaska.
3:26 Speaker 03 And I did it in a pretty decent time, too.
3:29 Speaker 02 Today on the show, Gleevec and how it ushered in a new era for cancer care. You're listening to Short Wave, a science podcast from NPR.
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5:01 Emily Kwong? Okay, Sydney, today we are talking about a revolutionary cancer drug. Developing a new drug, of course, is not easy. So what is the origin story of this one, Gleevec?
5:12 Speaker 02 Yeah, so it kind of starts with a setback. Oncologist Brian Drucker had this idea that at the time was really new in cancer medicine. He thought, what if, instead of just trying to kill cancer cells and hoping that the healthy cells were mostly spared, you could target the reason that cancer cells were growing out of control in the first place?
5:34 Speaker 05 What I saw with chemotherapy is that we were giving patients pretty toxic drugs. We didn't quite know if they'd work. And my view was there had to be a better way. And that better way had to be based on a knowledge of what was driving the growth of a specific cancer.
5:52 Emily Kwong? I mean, it makes total sense and is a pretty widely accepted idea now. But you're saying back then, no one had ever tried this kind of targeted approach before?
6:02 Speaker 02 We didn't because we didn't know what to target. There was a lot we didn't understand about cancers. And we learned it in chronic myeloid leukemia, which became one of the first cancers to be linked to a genetic abnormality, the Philadelphia chromosome. Scientists knew that people with this chromosome had a fused gene. That gene results in an abnormal enzyme that regulates one of the on/off switches for certain cell growth. This one gets stuck in the on position, leading to uncontrolled white blood cell growth, chronic myeloid leukemia. Brian was trying to turn that switch off. So he wanted to find a drug that would inhibit the abnormal enzyme.
6:43 Emily Kwong? That's brilliant. Yeah.
6:45 Speaker 05 The problem was, not a lot of people believed that was going to work.
6:49 Speaker 02 He said that his institution thought it was an interesting idea for a grant or something, but he ultimately had to leave his job in Boston and move across the country to Oregon Health and Science University to really actually pursue it.
7:05 Emily Kwong? Yeah, he's like, this is big science. I gotta take a risk here. Was it worth it?
7:10 Speaker 02 Well, he says that within six weeks of arriving, he was testing five compounds from the drug company that would become Novartis in his lab. One of them was Glivek. It was a compound discovered by scientist Nicholas Lyden, and it worked, at least in the lab.
7:29 Speaker 05 The reality is, I wasn't just a researcher. I also had patients, many, many patients who believed in me, thought that this was a potential way forward for them. And it allowed me to have enough courage to be their, their mouthpiece and voice to lobby to get this drug into clinical trials.
7:47 Emily Kwong? So it sounds like he was in a race against time, really, to try to save these patients' lives.
7:52 Speaker 02 Yeah, exactly. And these trials were also unique because they only included patients with this specific kind of leukemia.
8:00 Emily Kwong? Wait, so was that uncommon in cancer drug trials?
8:03 Speaker 02 No. Before this trial, cancer drug studies would include patients with all kinds of cancer. And they just sort of hoped that the drug worked for some of them.
8:11 Emily Kwong? They would just lump them all together?
8:13 Speaker 02 And for a few, it would become the standard of care. It would work. But for most people, the drug wouldn't work.
8:18 Emily Kwong? That's so interesting. But I guess Brian's trial, he wanted to focus just on this type of leukemia because his pill was designed to target that cancer and the thing causing the cancer.
8:30 Speaker 02 Exactly.
8:31 Emily Kwong? Yeah.
8:31 Speaker 02 Within six months, every CML, which is the abbreviation for chronic myeloid leukemia, patient taking more than 300 milligrams responded to the treatment.
8:42 Emily Kwong? Every patient?
8:42 Speaker 02 It was unheard of, Emily. And because it was 1999, it was also the early days of blogging and internet chatroom. So the patients were talking to each other.
8:56 Speaker 05 So all of a sudden, I was getting contacted by patients from around the world who wanted to enroll on this clinical trial.
9:04 Speaker 02 They knew that they had to scale up trials and get the drug application to regulators and like, fast. And that's where the folks at Novartis come in.
9:12 Emily Kwong? That's the drug company, right?
9:14 Speaker 02 Right. So the next step would be for a drug company to take the drug to the FDA for approval. To do that, you've got to look at the data and prepare a whole package. Enter Insa Gothman, who was right out of school and got hired as a biostatistician.
9:28 Speaker 06 And it was apparent back then that this is a game changer and that we needed people with energy who could make this drug development even faster and then bringing this to authorities as fast as we could.
9:42 Speaker 02 She became the statistical lead on the project, working long hours.
9:46 Emily Kwong? What was she doing?
9:47 Speaker 02 So one of her jobs was to look at survival curves.
9:50 Speaker 06 And when I was first running them for Gleevec, I was like, OK, I must have done a programming mistake, something is wrong. Because the curves were just, I mean, they were all doing fantastic and they were all alive. And I'm like, no, no, no, something is wrong. This can't be, can't be right.
10:07 Emily Kwong? But it was right.
10:08 Speaker 02 Yeah. So Gleevec was able to switch the enzyme to the off position, shutting down that cell overgrowth, which let patients' white blood cell counts return to normal.
10:19 Emily Kwong? This is so inspiring.
10:20 Speaker 02 Mm-hmm. And when Gleevec was approved on May 10, 2001, it was the fastest approval at the time. Seventy-two. Two days and everyone from the NIH to the FDA to the HHS secretary to the company executives wanted to take a bow. Amit Serpatori is an assistant professor of population medicine at Harvard Medical School and he says it was an example of the public and private sectors working together at their best to bring forward meaningful medical advancements.
10:50 Speaker 07 We have one of the most robust innovation systems in the world and that system in pharmaceuticals really relies on early-stage funding by the government of science, of medical research.
11:10 Speaker 02 And Emily, none of this would have happened without people knowing about the genetic mutation that causes this cancer in the first place, the Philadelphia chromosome. That discovery was funded by the National Cancer Institute, which is part of the NIH.
11:23 Emily Kwong? So this, even though it got approved in 72 days, that's because of years of work ahead of it and layers of cooperation from so many different groups.
11:34 Speaker 02 Cooperation and taking on risk. Remember, Brian Druker moved across the country. The drug company that would become Novartis took on the financial risk of doing the expensive clinical trials. The patients took a risk trying a new drug and then a whole bunch of people moved to heaven and earth to speed up the approval time. All of this changed medicine.
11:55 Speaker 07 You can think of it as really ushering in this era that we have now of targeted therapies, targeted cancer drugs on the market. There's now over 100 targeted cancer drugs on the market, which in many cases have meaningfully improved the overall survival and quality of life.
12:17 Speaker 02 Though I should add that Gleevec was also considered incredibly expensive when it launched at $26,000 a year. And that meant even more money back in the early 2000s.
12:26 Emily Kwong? Yeah.
12:27 Speaker 02 The drug is now generic and much cheaper.
12:30 Emily Kwong? So Gleevec is still being used today.
12:33 Speaker 02 Yep, it's still used. Brian still prescribes Gleevec and the second, third and fourth gen- Generation drugs that came after and he's still able to tell patients that they'll be able to live a normal life. He told me about one patient who had leukemia as a child and started taking Gleevec. Eventually, she was able to come off the drug with no recurrence of her cancer, and she now has two kids.
12:57 Speaker 05 Her parents thought that she would never live long enough to graduate from high school. And here she is with us today.
13:04 Speaker 02 And the researchers kept studying Gleevec and they found out it actually works for other cancers. For example, it can also treat a certain kind of gastrointestinal tumor by shutting off its out of control growth. Dr. Drucker, Brian remembers that he had this one patient who had one of these tumors that he said made his stomach look like he was nine months pregnant, and he was uncomfortable, he couldn't roll over in bed, he was miserable. And within days of starting Gleevec, Brian got a call. The patient was on the other end of the line and he said he felt so great that he was playing a round of golf.
13:41 Emily Kwong? Because Gleevec was able to like turn off the cell growth?
13:44 Speaker 02 Uh huh.
13:44 Emily Kwong? Wow. And Cindy, in marking the anniversary of Gleevec this week, where is everyone at now? All the people who helped make this possible? Like, um, that Swiss biostatistician?
13:56 Speaker 02 Insa, she stayed at Novartis and became the executive director in biostatistics, and she's about to retire.
14:02 Emily Kwong? And what about Mel, the dad?
14:03 Speaker 02 Mel, the dad, given three years to live in 1995. He's now 69 years old.
14:08 Emily Kwong? Wow.
14:08 Speaker 02 Yeah, he got to watch his daughter grow up. He even went back to school and got a second bachelor's degree, and he wants to run the Boston Marathon next.
14:16 Emily Kwong? Heck, yeah.
14:17 Speaker 03 I'm just thankful for the physicians who I know had to burn a lot of midnight oil to make it happen. And the researchers and, and people who were involved in the whole process. You know, the people at the sites, the, uh, people who crunched the numbers and just so many people that I have to be thankful for. So it means a lot, you know, I got a second chance at life.
14:42 Emily Kwong? Yeah. And what about Brian Drucker, the oncologist who really is responsible for a lot of this and figured out Gleevec?
14:49 Speaker 02 Yeah, he developed it. He's gotten to watch people given a death sentence actually go on to live normal lives. And some of them celebrated Gleevec's anniversary with him this past weekend.
15:00 Speaker 05 It is a remarkable and magic moment of reflection because some of the patients on that phase one, first in human trial, are still with me. And they've seen weddings, births, graduations, grandchildren, all the things that they never thought that they could imagine would happen.
15:26 Emily Kwong? Sydney, thank you so much for sharing this story and the science behind it.
15:31 Speaker 02 Thank you for having me.
15:33 Emily Kwong? If you liked this episode, share it with a friend because it really helps the show out. Also, check out the episode we did with Sydney on accelerated drug approvals and the development of the GLP-1 pills. This episode was produced by Hannah Chin. It was edited by Rebecca Ramirez. The fact checker was Tyler Jones. Jimmy Keely was the audio engineer. I'm Emily Kwong. Thank you for listening to Shore Wave from NPR.
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