Tuesday, July 29, 2014

Happy Day! FDA approves Imbruvica!

Monday, July 28, 2014 was a wonderful day! Our granddaughter was over at our house having a sleepover. She was born a year after I was diagnosed with leukemia. My son and his wife named her “Hope” to give me hope.

A few days ago on July 25, 2014 the news came in that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended ibrutinib (a.k.a. PCI-32765, brand name Imbruvica) for those with relapsed or refractory mantle cell lymphoma (MCL), CLL patients with one prior therapy, and [TRUMPETS, PLEASE] first-line use for those with 17p deletion or TP53 mutation who are not suitable for intravenous chemotherapy.

That was Europe. But in the U.S. the F.D.A. (U.S, Food and Drug Administration) approved the drug for MCL (November 2013), and those patients with prior CLL treatment (February 2014), but not for those with 17p deletion.

August 2009 I was diagnosed with CLL (a leukemia which is also a type of non-Hodgkin lymphoma) with deletion 17p (del17p) and TP53 mutation. Event though CLL is a chronic disease, I realized I had drawn the bad card… two to three years median predicted survival. The deletion and mutation status is linked with treatment-resistant and aggressive cancer. Loss of the key gene TP53 means the loss of triggering DNA repair or cell death in order to control the presence of abnormal tumors in the body.

Three years after diagnosis I was accepted in a clinical trial at the National Institutes of Health (NIH). Five years after diagnosis I am still here on this earth happily living on borrowed time. I really wanted other patients who did not get into a clinical trial to have the same blessings I have had.

Monday, July 28th Pat Elliott (a.k.a. CML social media queen) sent me the F.D.A. (U.S. Food and Drug Administration) news release that the FDA expanded the use of Imbruvica for those CLL patients who carry a deletion in chromosome 17. Good news, indeed. That means that all cancer patients with this diagnosis can be prescribed Imbruvica.

What a happy day!

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