Request to expand approval for Imbruvica (ibrutinib) to untreated patients with chronic lymphocytic leukaemia submitted to EMA- Janssen
Janssen has submitted a Type II variation application to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorisation for Imbruvica (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL). The filing is based on data from the randomised, multi-centre, open-label Phase III RESONATE-2 (PCYC-1115) clinical trial assessing the use of ibrutinib versus chlorambucil in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. At the time of the final analysis the primary endpoint was met, with ibrutinib shown to be superior to chlorambucil in terms of progression-free survival (PFS). In addition, ibrutinib demonstrated significant improvements in key secondary efficacy endpoints, including overall survival (OS), overall response rate (ORR) and in haematologic function. The safety findings were consistent with previous studies.
A similar request was submitted to the FDA in September 2015.
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