Supplemental NDA for Imbruvica (ibrutinib) in front line treatment of chronic lymphocytic leukemia submitted to FDA- Janssen Biotech

A supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib), from Janssen Biotech, has been submitted to the FDA for front-line use in patients with chronic lymphocytic leukemia (CLL). The filing is based on data from the randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) trial assessing the use of ibrutinib versus chlorambucil in patients with treatment-naive CLL or small lymphocytic lymphoma (SLL) aged 65 years or older.

Comment: 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. The Phase III data have been submitted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal. The drug is already indicated to treat people with CLL who have received at least one prior therapy also with CLL with 17p deletion.