- The European Commission (EC) has approved Johnson & Johnson (NYSE:JNJ) unit The Janssen Pharmaceutical Companies' supplemental marketing application for Imbruvica (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab (Roche's Rituxan) for previously untreated adult patients.
- The decision is based on data from the favorable results from Phase 3 E1912 study.
- “Ibrutinib is the most comprehensively studied Bruton’s tyrosine kinase inhibitor with the longest follow-up across eight positive Phase 3 trials in CLL to date,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development.
- Other than CLL, ibrutinib is approved in Europe for mantle cell lymphoma and Waldenström’s macroglobulinemia.