8 November 2019 - Supplemental new drug application -- submitted through FDA real-time oncology review program -- is based on positive Phase 3 data in patients aged 70 or younger.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval to expand the Imbruvica (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma.
The submission is based on positive results from the investigational Phase 3 E1912 study designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, which is part of the National Institutes of Health.