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FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL

Gina Columbus @ginacolumbusonc
Published: Friday, Nov 08, 2019

Danelle James, MD, MAS, Imbruvica Clinical Development Lead, Pharmacyclics LLC

Danelle James, MD, MAS

A supplemental new drug application (sNDA) has been submitted to the FDA for ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1

The sNDA is based on findings from the phase III E1912 trial, in which the combination demonstrated an 83% reduction in the risk of death compared with standard fludarabine, cyclophosphamide, and rituximab (FCR) after a median follow-up of 33.6 months (HR, 0.17; 95% CI, 0.05-0.54; P <.001)2,3 Additionally, there was a 65% reduction in the risk of progression or death with Ibrutinib/rituximab versus FCR (HR, 0.35; 95% CI, 0.22-0.56; P <.001).  

Moreover, safety data were consistent with the known tolerability of ibrutinib. Four-year follow-up findings of the phase III trial will be presented at the 2019 ASH Annual Meeting, AbbVie, which jointly develops ibrutinib with Janssen Biotech, Inc., stated in a press release.

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