Janssen Seeks Approval of IMBRUVICA ®(ibrutinib) in a Fixed-Duration Regimen for Patients with Untreated Chronic Lymphocytic Leukaemia (CLL)

BEERSE, BELGIUM, 30 November 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new treatment option for IMBRUVICA® (ibrutinib) as a fixed-duration combination with venetoclax (I+V) for adult patients with previously untreated chronic lymphocytic leukaemia (CLL)."Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past seven years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,” said Dr. Edmond Chan, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Ltd. “This latest submission is a testament to our unwavering commitment to meeting patient needs and a noteworthy step towards an innovative, non-chemotherapy treatment regimen in the first-line setting that will allow healthcare professionals the flexibility to use ibrutinib either in a fixed-duration combination treatment regimen or as continuous therapy, depending on patient needs.”The submission is supported by positive data from the pivotal Phase 3 GLOW study (NCT03462719) which investigated the efficacy and safety of first-line fixed-duration I+V versus chlorambucil plus obinutuzumab in elderly or unfit patients with CLL,1 and the Phase 2 CAPTIVATE study (PCYC-1142) which evaluated I+V in previously untreated CLL patients 70 years or younger, including patients with high...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news