FDA approves Imbruvica as first-line therapy for chronic lymphocytic leukemia
AbbVie researchers conducted a randomized, multi-center, open-label phase-three trial on Imbruvica.
"The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging," Jan Burger, lead investigator of the most recent Imbruvica study, said. "This is especially important for first-line CLL patients, when considering the safety profile. This treatment represents another option for these patients."
It is estimated that 115,000 people in the U.S. are living with CLL and that 15,000 new patients are diagnosed annually. The average age of patients at the time of CLL diagnosis is 71.
"This approval represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy," Michael Severino, chief scientific officer for AbbVie, said. "AbbVie is committed to making significant improvements in the lives of patients with hematologic malignancies and will continue to explore ways to improve treatment options for patients."
The National Comprehensive Cancer Network (NCCN) endorses the use of Imbruvica as a CLL therapy.
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