AbbVie’s Imbruvica gets US FDA okay as first-line treatment for CLL
pharmafile | March 7, 2016 | News story | Sales and Marketing | AbbVie, Janssen, Janssen Biotech, US FDA, imbruvica
Drug maker AbbVie said the US Food and Drug Administration (FDA) has approved its Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).
Imbruvica is jointly developed and marketed by Pharmacyclics, a unit of AbbVie and Janssen Biotech, Inc.
Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie, said, “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. 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 approval is based on data from the Phase III study, evaluating the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. The data were previously presented at the American Society of Hematology (ASH) Annual Meeting in December 2015.
About 115,000 patients in the US have CLL with nearly 15,000 newly diagnosed patients every year. CLL is a disease of elderly patients, with an average diagnosis age of 71.
Dr. Jan BurgerAssociate lead study investigator for the late stage trials, said, “The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging. This is especially important for first-line CLL patients, when considering the safety profile. This treatment represents another option for these patients.”
Anjali Shukla
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