This week the US Food and Drug Administration (FDA), as expected, approved ibrutinib, now known as Imbruvica, for CLL patients who have tried at least one prior therapy.
This week the US Food and Drug Administration (FDA), as expected, approved ibrutinib, now known as Imbruvica, for CLL patients who have tried at least one prior therapy. It gives the hope of being a one-pill-a-day treatment and giving a new lease of life for some of the sickest CLL (chronic lymphocytic leukemia) patients and could, over time, be a good choice for a wider group of patients. My friend, Dr. Brian Koffman, is one such patient who attended, as a family doctor and patient, the 2011 conference of the American Society of Hematology in search of a clinical trial that could benefit him as his health was going downhill fast. Brian connected with Dr. John Byrd from Ohio State and was able to enroll in Dr. Byrd’s trial of Imbruvica in Columbus, Ohio. Brian is from Southern California and had to commute back and forth many times and live in an apartment near the Ohio State’s James Cancer Center. We have Brian and many other patients to thank for the new drug’s approval and, happily, Brian is now doing much better! Recently, I interviewed Brian as he continued his mission of helping others by going from medical conference to medical conference in the US and Europe, with his son as videographer, and speaking with CLL experts. In anticipation of new drug approvals, here is the advice Brian gives to patients so they get the best treatment for them.
As Brian noted, Imbruvica is only one of several new treatments here now or coming fairly soon. A few months ago a new monoclonal antibody was approved in the US, obinutuzumab or Gazyva. Perhaps this year we’ll have another pill, idealisib. And after that a drug with, still, only an acronym and a number, ABT199. And some doctors continue to like another pill, lenalidomide, originally meant for myeloma, . How does it all work together or in sequence? Who should get what and when? What questions should you be asking your doctor and how can you help THEM stay informed? These are good challenges to have because it means there’s lots to talk about. My interviews with CLL expert Dr. Jeff Sharman dealt with these topics. One on what’s coming (with one new drug now here) and the other on what treatments to consider and when .
Obviously, other experts will weigh in and we’ll bring you those perspectives on video. There continues to be debate on whether anyone should still get a chemotherapy agent. We’ll take your questions as we will soon launch a regular “Ask the Expert” video series where you can send us questions to email@example.com and we’ll do our best to get answers that can benefit you and others.
As new drugs come out, it is good news for the estimated 114,000 people living with CLL in the US and many more around the world (my UK friends tell me there are about 30,000 there). But sadly, I have known CLL patients who have died before any of these new products were available. And one died in an early trial for one of the promising new drugs. Progress is not a straight line. While it is great news that a new, effective pill is available for CLL, how long does the effect last? Does one develop resistance to it at some point? And another issue, any of these new drugs are, or will be, very expensive. Who will pay? And for how long? What if we need TWO expensive drugs in combination – for life? And, as we have seen in CML leukemia, can there be the hope that some patients could take the pill and have the disease be knocked back so low that our own immune systems can take over and we can stop taking the medicine? I don’t know if this applies in CLL but one wonders. The point is a new drug approval is a first step and it is cause to celebrate, but wisely. Will there be longer term side effects or will this be a triumph of medical science? We’ll cover that story and be on the journey with you together.
What’s also exciting is that CLL progress is but one example. More is happening in myeloma, in lymphomas, in myeloproliferative neoplasms (MPNs), lung cancer, and melanoma. I am optimistic and only wish the list of accelerating progress could extend to more cancers. But this latest approval is a great beacon of hope. If you have CLL, talk to your doctor about whether it applies to you now or could in the future. We’ll do our best to help you stay informed.