Jamie DePolo: Hello, and welcome to the Breastcancer.org February 2015 Research News podcast. I’m your host, Jamie DePolo, the senior editor of Breastcancer.org. Our guest today is Dr. Brian Wojciechowski, Breastcancer.org’s medical adviser. And the topic today is the medicine Ibrance, which was just granted accelerated approval by the U.S. Food and Drug Administration. So, to get started, Dr. Brian, let’s go over the basics of Ibrance: Who is it for? How is it given, and how does it work?
Dr. Brian Wojciechowski: So, the basics about Ibrance is that it’s a new oral drug, so it’s taken by mouth, in combination with a drug that is already on the market for breast cancer, and that’s Femara, which is a hormonal therapy that many of our readers are going to be familiar with already. Ibrance is something called a kinase inhibitor, and what it inhibits is the cell cycle protein CDK4/6. What’s the cell cycle? Well, one of the things a cancer cell needs to do in order to grow and spread is divide, and the process of cell division is called the cell cycle. So, this drug inhibits that cell cycle, so it inhibits the process of cancer cells dividing and growing.
Jamie DePolo: Okay.
Dr. Brian Wojciechowski: The patients who are going to be able to take this medication are patients with advanced or metastatic breast cancer who have not yet had a hormonal therapy. And this could be someone who is recently diagnosed with advanced breast cancer that is hormone receptor-positive, so estrogen and progesterone receptor-positive. It could be someone who had early-stage breast cancer in the past and has now had a recurrence. It could also be a man if he has breast cancer and his cancer is hormone receptor-positive, and he now has advanced or metastatic disease. Some patients will have already had chemotherapy before their hormone therapy, and this drug would also be appropriate for those patients as well.
Jamie DePolo: Let me just clarify, too, because I know some people have had questions. So, say I’m a woman, I was diagnosed with early-stage, hormone receptor-positive breast cancer that was treated with hormonal therapy. Now the cancer has come back, it’s metastatic. Am I still eligible for Ibrance?
Dr. Brian Wojciechowski: Yes.
Jamie DePolo: Okay, so it’s the metastatic disease that has not been treated with hormonal therapy before.
Dr. Brian Wojciechowski: That’s exactly right, Jamie.
Jamie DePolo: Okay, okay perfect. And, also, I want to point out that because it’s always given with Femara, a person would never take Ibrance alone, correct?
Dr. Brian Wojciechowski: That’s correct according to the FDA indication.
Jamie DePolo: Okay, so this would be, then, for post-menopausal women.
Dr. Brian Wojciechowski: Yes, certainly anyone taking this would have to be post-menopausal.
Jamie DePolo: Okay, okay great. Now, how long do people take Ibrance?
Dr. Brian Wojciechowski: Since the drug is for advanced or metastatic disease, the patient would take it until it’s no longer working. So, your doctor would do periodic assessments including scans, physical exams, or lab work, and when it’s determined that the cancer is growing despite the drug, that’s when you would stop it and perhaps change to something else.
Jamie DePolo: Okay. And as I understand it, too, Ibrance is a little bit different than some of the other hormonal therapies in that you take it in cycles.
Dr. Brian Wojciechowski: That’s right. Typically, for hormonal drugs, for example, like Femara or Arimidex or Aromasin, a patient is taking it every day continuously. But Ibrance is different in the sense that you’re taking it once a day for 21 days, then you get a 7 day break, and then you start all over again. And that’s considered one cycle. So, one cycle lasts for 28 days.
Jamie DePolo: Okay. And it’s also my understanding, too, so if a person were on Ibrance they would take it for that 21 days. They would not take it for the 7 days, but while that 7 days were going on where they were not taking Ibrance they would still take the Femara, correct?
Dr. Brian Wojciechowski: That’s correct.
Jamie DePolo: Okay, perfect. Now, what about side effects?
Dr. Brian Wojciechowski: Yes, so side effects of this drug most commonly would include trouble with blood counts, so decreased red blood cells, which is also called anemia, and that affects the energy and the oxygen carried in the body. And also decreased white blood cells, which can make you more susceptible to infection. If patients do get into problems with decreased blood cells, what can be done is that the dose of the drug can be decreased with the next cycle, and that usually helps.
Jamie DePolo: Okay. Are there any other… I would guess, less severe -- what are the most common side effects? Is anemia and low white blood cell count, are those very common with Ibrance or are those some of the more severe ones?
Dr. Brian Wojciechowski: Those are fairly common. I think probably more common would be just plain fatigue. A severe side effect of Ibrance includes pulmonary embolism, which is blood clots in the arteries of the lungs, which can be life-threatening.
Jamie DePolo: Okay, okay.
Dr. Brian Wojciechowski: And you certainly would not want to take this drug if you were pregnant.
Jamie DePolo: Right, right, I had read that as well. Okay, so we talked about the side effects. We’ll talk a little bit about the insurance coverage for that at the end, but before we get to there I wanted to ask you, what does accelerated approval mean, and will there be other trials or studies on Ibrance?
Dr. Brian Wojciechowski: Well, that’s a great question. So, the FDA has several different programs to get important drugs to the market quicker than they otherwise would. Accelerated approval is when the FDA approves a drug based on non-traditional endpoints, or what we would consider somewhat inferior data. So, Ibrance, for example, is approved based on a benefit in progression-free survival, so the amount of time that women live without the cancer progressing or getting worse. It was not based on overall survival benefit, meaning how long the patient lived until they died. So, the FDA thought this drug was important enough and new enough, and they thought the preliminary data was good enough that they gave it this designation and approved it. Now, there’s an ongoing study called the PALOMA trial. PALOMA is the name of the trial. It also happens to mean "dove" in Spanish. And depending on the results of this study, this large study, if the results look good, then the drug will receive traditional FDA approval. But if it does not look good then the drug could be subject to being taken off the market at that point.
Jamie DePolo: Oh, okay.
Dr. Brian Wojciechowski: But it does get the drugs to patients sooner than it otherwise would.
Jamie DePolo: Okay, okay, and I should point out that if anybody listening was in a clinical trial to test this medicine, it was called palbociclib, so you may have heard us talk about that earlier. Before it was being marketed and approved, it did not have a brand name, so it was just known by its chemical name, which is palbociclib, and now it’s called Ibrance. So also, if you’re looking on the Breastcancer.org website for information, there are some older research studies that talk about palbociclib. So just so everybody knows that. Now as far as insurance coverage, insurance is going to cover this, but you do need to go through a specialty pharmacy and talk to your doctor and work with your doctors and the special pharmacy to ensure that your insurance company is covering it and that you get it delivered to your home and things like that, correct?
Dr. Brian Wojciechowski: Yes, it is a very expensive drug. It’s a specialty drug, and you can’t get this at the corner drug store.
Jamie DePolo: Okay. And it’s my understanding, too, so when you work with a specialty pharmacy, the navigator there then kind of works with you and the medicine is actually delivered to your home.
Dr. Brian Wojciechowski: Yes, that’s usually how it works. Some doctors have navigators they work with in their own office. I know that when my patients get drugs like this they’re going to work with my navigator and my nurses as a team with the specialty pharmacy, and the drug gets approved and delivered to the patient’s home usually within a week or two of prescribing it.
Jamie DePolo: Okay perfect. Well, thank you so much, Dr. Brian. This has been very illuminating. Is there anything else that we’ve overlooked about Ibrance?
Dr. Brian Wojciechowski: No, I just think this is a very exciting drug. The preliminary data is very strong and very promising, and my expectation is that this will change the standard of care.
Jamie DePolo: Okay, okay, well, thank you very much, and please everyone tune in next month when we’ll talk about another Research News topic.
