Janssen Biotech seeks FDA approval to use drug on leukemia patients

Janssen Biotech said on Monday that it has submitted a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration for front-line use in patients with chronic lymphocytic leukemia (CLL).

"This submission to expand the use of IMBRUVICA for patients with treatment-naive CLL is very significant, as this patient population represents the largest group of patients with CLL," Dr. Peter Lebowitz, global oncology head of Janssen Research and Development LLC, said. "The submission highlights our commitment to developing medicines that truly transform treatment paradigms and patient outcomes, as well as our commitment to further develop IMBRUVICA in hematologic malignancies."

The filing was based on data from a randomized, multi-center, open-label Phase 3 RESONATE-2 (PCYC-1115) trial that evaluated the use of ibrutinib vs. chlorambucil in patients with treatment-naive CLL or small lymphocytic lymphoma (SLL) age 65 years or older.

"Treatment-naive patients with this disease typically relapse or become refractory to standard chemotherapy, so new options are greatly needed to potentially change the CLL/SLL treatment paradigm," Jan Burger, associate professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center and the study's lead investigator, said.

Janssen and Pharmacyclics are continuing a clinical development program for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.

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Janssen Biotech, Inc. 800 Ridgeview Dr Horsham, PA - 19044