AbbVie announced the Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. Imbruvica is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR). Imbruvica is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
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"Our robust clinical research program with Imbruvica continues to reinforce the evidence for its use as an efficacious treatment option in CLL and SLL, this time versus a National Comprehensive Cancer Network guidelines Category 1 treatment, which is the chemoimmunotherapy combination of chlorambucil plus obinutuzumab," said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. "Further, for the first time in CLL, results from iLLUMINATE have shown the potential benefits of using an Imbruvica -based, chemotherapy-free, anti-CD20 combination. Since its initial approval five years ago, Imbruvica has received nine FDA approvals across six different diseases, and we remain committed to advancing new research to understand its full potential in blood cancers like CLL and SLL, as well as other difficult-to-treat diseases with unmet medical needs."
The sNDA submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial announced in May 2018, which showed IMBRUVICA plus obinutuzumab was associated with significantly longer progression-free survival (PFS) versus chlorambucil plus obinutuzumab in adults with previously untreated CLL/SLL, as assessed by an Independent Review Committee.
CLL is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). While these cancer cells start in the bone marrow, they then later spread into the blood. The prevalence of CLL is approximately 115,000 patients in the U.S. with approximately 20,000 newly diagnosed patients every year. SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal. CLL/SLL are predominately diseases of the elderly, with a median age diagnosis ranging from 65-70 years.