Imbruvica sNDA for Expanded CLL Indication Submitted to FDA
Janssen Biotech and Pharmacyclics announced that it has submitted to the Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) for front-line use in patients with chronic lymphocytic leukemia (CLL).
The NDA filing is based on results from RESONATE-2, a randomized, multi-center, open-label Phase 3 trial assessing the use of ibrutinib vs. chlorambucil in patients ≥65 years old with treatment-naive CLL or small lymphocytic lymphoma (SLL). At the time of the final analysis, the primary endpoint was met, demonstrating ibrutinib to be superior to chlorambucil in terms of progression-free survival (PFS).
Imbruvica is a Bruton's tyrosine kinase (BTK) inhibitor currently indicated for the treatment of patients with CLL who have received at least one prior therapy, CLL with 17p deletion, Waldenstrom's macroglobulinemia (WM) and Mantle cell lymphoma (MCL) who have received at least one prior therapy.
For more information call (800) 526–7736 or visit JanssenBiotech.com.