IMBRUVICA Treats CLL and SLL Patients Without Chemotherapy
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"I hadn't been to the doctor for a really long time 'cause I was healthy. So I went for a regular, routine checkup, and he felt a lump on the left side of my jaw. So he sent me for a CT scan, and that's when they discovered tons of nodes all through my upper chest and neck and jaw. After the biopsy results, I was diagnosed with Chronic Lymphocytic Leukemia," tells Tina, an IMBRUVICA patient who described her treatment journey in a moving video.
After experiencing terrible side effects, Tina thought that she may die. "That's the first time I really thought that I might not make it." She went through doctor after doctor, even moving across the country, before eventually attempting chemotherapy. "I stopped them midway, I didn't want to do any more treatments."
Finally, her doctor told her about IMBRUVICA, discussing the potential benefits and risks. Soon after Tina began taking the drug, her doctor was extremely satisfied with her progress, adjusting from a weekly appointment to just once every two months.
IMBRUVICA, or Ibrutinib, is a medication “used to treat certain cancers (such as mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body's defense system (immune system)."
IMBRUVICA is a once-daily oral therapy, and describes itself as working differently than other treatments such as chemotherapy. "IMBRUVICA® works by blocking the activity of a protein called Bruton's tyrosine kinase, or BTK. BTK is a protein involved in communication signals within B cells. By blocking BTK, IMBRUVICA® may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. BTK is also found in normal B cells, so blocking it may cause side effects. A relationship between how IMBRUVICA® works and why it helps to treat certain diseases has not been clearly identified."
The FDA greenlit the drug for the 10th time in January of this year, with approval being "based on results from the Phase III iLLUMINATE study that showed the combination treatment significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Trial results showed that patients who were treated with the combination of Imbruvica and Gazyva experienced a 77% reduction in risk of progression or death compared to the chemotherapy arm. AbbVie said the chemotherapy-free, anti-CD20 combination regimen also showed an 85% reduction in risk of progression or death compared to chlorambucil plus obinutuzumab when evaluating PFS in patients with high-risk disease."
Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead iLLUMINATE investigator quoted that "This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. Also, and importantly, this new treatment combination helps reduce the need for chemotherapy."
IMBRUVICA even offers a YOU&i™ Support Program, "a personalized program that helps your patients learn about access to IMBRUVICA® (ibrutinib), find affordability support options, and sign up for information and resources to support them along their treatment journey." New patients experiencing insurance coverage delays can "receive a free 30-day supply of IMBRUVICA®. The free product is offered to eligible patients without any purchase contingency or other obligation." The program includes resources such as a list of specialty pharmacies and distributors, a sample letter of medical necessity, affordability support options, nurse call support, and various other clinical resources.
Tina describes a great change in her quality of life since starting IMBRUVICA to close out her treatment journey video. "My outlook has changed since I started taking IMBRUVICA. I feel that I am much more capable of moving forward and taking care of myself first. It comforts me a great deal to know that my friends and my doctor are totally by my side. They have meant everything to me through this whole process. I am very happy to have IMBRUVICA as my treatment. The advice I give for people who are diagnosed with CLL is do the research, advocate for yourself, and never give up until you find the treatment and the doctor who are right for you."