On January 20, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II variation application to the European Medicines Agency (EMA) seeking to expand the label of IMBRUVICA (ibrutinib) to include ibrutinib in combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukaemia (CLL) (Press release, Johnson & Johnson, JAN 20, 2020, View Source [SID1234553343]).
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The submission is supported by data from the Phase 3 E1912 study, designed and conducted in the United States (U.S.) by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), which is part of the U.S. National Institutes of Health. The study evaluated 529 patients with previously untreated CLL aged 70 years or younger, who were randomly assigned in a 2:1 ratio to receive ibrutinib plus rituximab (n=354) or the chemo-immunotherapy FCR (n=175). The primary endpoint was progression-free survival (PFS) and one of the secondary endpoints was overall survival (OS).1 The primary study results were previously published in The New England Journal of Medicine, and the extended four-year median follow-up results were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.1,2
"The ECOG-ACRIN’s E1912 study demonstrated that ibrutinib in combination with rituximab has shown superior PFS and OS versus FCR, a chemotherapy-based standard of care for younger patients with newly diagnosed CLL," said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag. "We look forward to working with regulatory authorities to bring ibrutinib to more patients with CLL who may benefit from treatment."
"The E1912 study demonstrated the important clinical benefit of ibrutinib in combination with rituximab in the frontline setting," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC. "We remain committed to replacing long-standing use of chemotherapy with ibrutinib-based combination regimens for the treatment of patients with CLL in the frontline setting."
About ibrutinib
Ibrutinib is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally.3 Ibrutinib blocks the BTK protein; the BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.4 By blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.5
Ibrutinib is currently approved in Europe for:3
Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 95 countries for at least one indication, and to date, has been used to treat more than 170,000 patients worldwide across its approved indications.6
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.3
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.
About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.7 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.8 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.9
The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.