Patients suffering from chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) can now be treated with a mix of Imbruvica (ibrutinib) and Gazyva (obinutuzumab). This is the first approach that does not include chemotherapy and at the same time integrates a CD20 antibody.
“We are living in a time of significant advances in cancer treatment, particularly in blood cancers, and this latest Imbruvica FDA approval is an example. I am proud that we can now give physicians and patients a new option to treat CLL and SLL without the need for chemotherapy”, stated Danelle James, MD, head of clinical science at producing company AbbVie.
Imbruvica is an effective inhibitor of Bruton’s tyrosine kinase (BTK), a molecule that malignant B-cells require in order to survive and proliferate. The monoclonal antibody Gazyva has receptors that bind to CD20, a protein found on the surface of B-cells, leading to the destruction of these cells, either directly or indirectly via immune system mediators.
The FDA decision comes after a Phase 3 trial where a combination of Gazyva and Imbruvica significantly delayed disease progression or death. The study enrolled 229 patients with CLL/SLL from different centers around the world, including Australia, Canada, Europe, Russia, New Zealand , and the United States.
At 30 months into the program, 79% of those receiving Imbruvica were alive and progression-free, compared to 31% in the control group, accounting for a 77% decrease in the risk of cancer progression or death. Patients at higher risk saw even better improvements as the treatment managed to lower the risk of disease progression or death by 85%.
“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,” said lead investigator Carol Moreno, MD, PhD.
This is an important milestone for the oncology field in general and patients with lymphoma and leukemia in particular.
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