Janssen Announces European Commission Approval of Imbruvica (ibrutinib) for Expanded Use in Two Indications
Decision represents the fifth European approval in five years
August 13, 2019 07:08 AM Eastern Daylight Time
BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved variations to broaden the use of Imbruvica??(ibrutinib) in two indications. This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenstr?m's macroglobulinemia (WM).?The approval follows the Positive Opinion from the European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019.
1?Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial.?Lancet Oncol. 2019;20:43-56. 2?Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenstr?m?s macroglobulinemia. New England journal of medicine. 2018 Jun 21;378(25):2399-410. 3?Buske C, Tedeschi A, Trotman J, et al. Ibrutinib treatment in Waldenstr?m's macroglobulinemia: follow-up efficacy and safety from the iNNOVATE??study.?Blood. 2018;132(Suppl.1):abstract 149. 4?ClinicalTrials.gov. A multi-center study of ibrutinib in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in patients with treatment na?ve CLL or SLL. NCT02264574. Available at:?https://clinicaltrials.gov/ct2/show/NCT02264574Last accessed August 2019. 5?ClinicalTrials.gov. Ibrutinib with Rituximab in Adults with Waldenstrom?s Macroglobulinemia. NCT02165397. Available at:?https://clinicaltrials.gov/ct2/show/NCT02165397?Last accessed August 2019. 6?O?Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial.?Lancet Oncol. 2014;15:48-58. 7?European Medicines Agency. Imbruvica (ibrutinib): an overview of Imbruvica and why it is authorised in the EU. Available at:?https://www.ema.europa.eu/documents/overview/imbruvica-epar-summary-public_en.pdf?Last accessed August 2019. 8?Imbruvica Summary of Product Characteristics, May 2019. Available at:?https://www.ema.europa.eu/documents/product-information/imbruvica-epar-product-information_en.pdf?Last accessed August 2019. 9?American Cancer Society. What is chronic lymphocytic leukemia? Available at:?https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html?Last accessed August 2019. 10?Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project.?Blood. 2010;116:3724?34. 11?Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.?Ann Oncol.?2015;26 (Suppl.5) :v78-v84. 12?Macmillan. Waldenstr?m?s macroglobulinemia. Available at:?https://www.macmillan.org.uk/information-and-support/lymphoma/lymphoma-non-hodgkin/understanding-cancer/types-of-non-hodgkin-lymphoma/waldenstroms-macroglobulinaemia.html?Last accessed August 2019. 13?European Waldenstr?m?s Macroglobulinemia Network. Waldenstr?m?s macroglobulinemia (WM). Available at:?https://www.ewmnetwork.eu/?Last accessed August 2019. 14?Kastritis E, Leblond V, Dimopoulos MA, et al. ESMO Guidelines Committee. Waldenstr?m?s macroglobulinaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2018 Jul 5;29 (Supplement 4) :iv41-50. CP-104965 August 2019
?The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively,? said Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies. ?These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers.? The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in?The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.1 In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the?New England Journal of Medicine.2?The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3 Additional information about both studies can be found at?www.ClinicalTrials.gov?(NCT02264574 and NCT02165397).4,5 ?With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients,? said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. ?We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies.? Ibrutinib, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.?We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies.?
Tweet this
#ENDS#
About ibrutinib Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6?By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7 Ibrutinib is currently approved in Europe for:8- 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
- Waldenstr?m?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
###
References1?Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial.?Lancet Oncol. 2019;20:43-56. 2?Dimopoulos MA, Tedeschi A, Trotman J, et al. Phase 3 trial of ibrutinib plus rituximab in Waldenstr?m?s macroglobulinemia. New England journal of medicine. 2018 Jun 21;378(25):2399-410. 3?Buske C, Tedeschi A, Trotman J, et al. Ibrutinib treatment in Waldenstr?m's macroglobulinemia: follow-up efficacy and safety from the iNNOVATE??study.?Blood. 2018;132(Suppl.1):abstract 149. 4?ClinicalTrials.gov. A multi-center study of ibrutinib in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in patients with treatment na?ve CLL or SLL. NCT02264574. Available at:?https://clinicaltrials.gov/ct2/show/NCT02264574Last accessed August 2019. 5?ClinicalTrials.gov. Ibrutinib with Rituximab in Adults with Waldenstrom?s Macroglobulinemia. NCT02165397. Available at:?https://clinicaltrials.gov/ct2/show/NCT02165397?Last accessed August 2019. 6?O?Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial.?Lancet Oncol. 2014;15:48-58. 7?European Medicines Agency. Imbruvica (ibrutinib): an overview of Imbruvica and why it is authorised in the EU. Available at:?https://www.ema.europa.eu/documents/overview/imbruvica-epar-summary-public_en.pdf?Last accessed August 2019. 8?Imbruvica Summary of Product Characteristics, May 2019. Available at:?https://www.ema.europa.eu/documents/product-information/imbruvica-epar-product-information_en.pdf?Last accessed August 2019. 9?American Cancer Society. What is chronic lymphocytic leukemia? Available at:?https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html?Last accessed August 2019. 10?Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project.?Blood. 2010;116:3724?34. 11?Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.?Ann Oncol.?2015;26 (Suppl.5) :v78-v84. 12?Macmillan. Waldenstr?m?s macroglobulinemia. Available at:?https://www.macmillan.org.uk/information-and-support/lymphoma/lymphoma-non-hodgkin/understanding-cancer/types-of-non-hodgkin-lymphoma/waldenstroms-macroglobulinaemia.html?Last accessed August 2019. 13?European Waldenstr?m?s Macroglobulinemia Network. Waldenstr?m?s macroglobulinemia (WM). Available at:?https://www.ewmnetwork.eu/?Last accessed August 2019. 14?Kastritis E, Leblond V, Dimopoulos MA, et al. ESMO Guidelines Committee. Waldenstr?m?s macroglobulinaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2018 Jul 5;29 (Supplement 4) :iv41-50. CP-104965 August 2019