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Wednesday, November 13, 2013

Ibrutinib gets first approval in Mantle Cell Lymphoma

Not sure if you caught the news (see NY Times) but the FDA has now approved ibrutinib (now called Imbruvica) for treatment of patients with mantle cell lymphoma (see my post on the different types of NHL). 

ASCO has put out a broadcast so that you can see the data here.

The label is fairly broad (approved for patients who have had one prior therapy).  That is significant because historically drugs that have been approved on the basis of single arm phase II studies (read NEJM article here) have required patients to have had exposure to all approved drugs in a particular disease.  In mantle cell lymphoma, that would include bortezomib which does not have a huge role in the management of the disease.  Keep in mind that lenalidomide was also recently approved in this disease. You can tell by stock price that the analysts think this is a good result for the company.

This is great news for MCL patients as it will give another treatment option.  Furthermore, once approved it will allow for a lot more research to begin taking place.  Not sure how much off label use will be allowed (will vary from insurance to insurance), but certainly hoping that the CLL indication comes soon.