Sunday, April 7, 2013

History of Ibrutinib

Where do drugs come from?  Sometimes they come from places far removed from where they were originally intended to go.  The history of ibrutinib development is detailed in this article published in Forbes magazine.  As David aptly points out – these drugs can come out of left field with wild histories.  Lots of people played important roles – and I think it is a fantastic read.  I would highly encourage any patient with CLL or NHL take the time to read it (yes I am proud to get a couple of personal mentions).

Ibrutinib is coming soon.  The FDA has given signals that it may receive preliminary approval toward the end of this year or early next year.  This drug combines impressive clinical efficacy with limited toxicity – a formula that is very exciting for patients with the disease.  It may seem like things are moving at a glacial pace (read my post on why it takes so long), but in the perspective of many people close to the action – it is clear that this is getting moved as quickly as things can go.

Unfortunately the initial approval will not serve as broad permission for any oncologist to prescribe it to any patient.  It will probably have a narrow, “indication” at first for patients with relapsed Waldenstrom’s Macroglobulinemia and MantleCell Lymphoma having received some specific prior therapies.  Second – I predict that patients with 17pdeleted CLL will get the next, “indication.  Over the next 1-3 years we will see the “indications” slowly expand in different patient populations

“Indications” matter because insurance companies pay close attention to what the FDA has approved.  Different insurance companies take very different attitudes regarding “off label” prescribing of drugs.  For a drug likely to cost nearly $90k per year (my guess only) – insurance will likely look quite closely at who is receiving it.  While CLL patients will greet the approval – it may still take a while for them to access the medicine.  That is why getting involved in research studies is so important!!!!