FDA Sends Valentine to CLL Patients
FDA Sends Valentine to CLL Patients
Of importance, however, ibrutinib is active across the broad spectrum of prognostic groups -- mutated or unmutated, ZAP-70 positive or ZAP-negative. Even in patients with the dreaded 17p deletion, the drug is active and responses can be durable. As a result, it is being studied in several front-line trials. For example, in the cooperative groups there are 2 such studies, one in older patients -- BR vs IR [ibrutinib, rituximab] vs ibrutinib alone -- and in younger patients, it's FCR vs IR. These 2 studies have the potential to totally change how we approach patients with CLL. We have been moving towards a chemotherapy-free world, and this is an opportunity to do so.
Now, there are a couple of issues. There will be a temptation to use this drug upfront in CLL even though that is not a labeled indication. First of all, it should not be used in patients for whom watch-and-wait remains an appropriate strategy because it is very expensive (more than $100,000/year). It does have adverse effects, and we don't know the long-term complications of being on the drug for many years. Second, there are some who argue that 6 months of chemotherapy, whether it is FCR or BR, with responses lasting for several years, might be preferable to having to take a pill continuously, indefinitely.
We can debate that back and forth, but nevertheless, this is a very exciting time. It is a Valentine's present for patients with CLL because it is a game-changer. We don't see many of these. It will revolutionize how we treat patients with CLL. Now we are waiting for approval for other indications for this drug, such as Waldenstrom macroglobulinemia, for which this appears to probably be the most effective drug. The drug had been approved for mantle cell back in December, and now CLL. For those of you who take care of patients with CLL, here is a great treatment option for those who have failed primary therapy. Consider ongoing studies for those patients as well. This is Bruce Cheson, signing off for Medscape Hematology. I will be speaking with you again in the near future. Thank you.
Active Across Broad Spectrum of Patients
Of importance, however, ibrutinib is active across the broad spectrum of prognostic groups -- mutated or unmutated, ZAP-70 positive or ZAP-negative. Even in patients with the dreaded 17p deletion, the drug is active and responses can be durable. As a result, it is being studied in several front-line trials. For example, in the cooperative groups there are 2 such studies, one in older patients -- BR vs IR [ibrutinib, rituximab] vs ibrutinib alone -- and in younger patients, it's FCR vs IR. These 2 studies have the potential to totally change how we approach patients with CLL. We have been moving towards a chemotherapy-free world, and this is an opportunity to do so.
Now, there are a couple of issues. There will be a temptation to use this drug upfront in CLL even though that is not a labeled indication. First of all, it should not be used in patients for whom watch-and-wait remains an appropriate strategy because it is very expensive (more than $100,000/year). It does have adverse effects, and we don't know the long-term complications of being on the drug for many years. Second, there are some who argue that 6 months of chemotherapy, whether it is FCR or BR, with responses lasting for several years, might be preferable to having to take a pill continuously, indefinitely.
We can debate that back and forth, but nevertheless, this is a very exciting time. It is a Valentine's present for patients with CLL because it is a game-changer. We don't see many of these. It will revolutionize how we treat patients with CLL. Now we are waiting for approval for other indications for this drug, such as Waldenstrom macroglobulinemia, for which this appears to probably be the most effective drug. The drug had been approved for mantle cell back in December, and now CLL. For those of you who take care of patients with CLL, here is a great treatment option for those who have failed primary therapy. Consider ongoing studies for those patients as well. This is Bruce Cheson, signing off for Medscape Hematology. I will be speaking with you again in the near future. Thank you.
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