European Commission approves IMBRUVICA in two forms of blood cancer

This new approach to treating blood cancers works by blocking BTK, a protein that helps certain cancer cells live and grow.¹ IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.²

IMBRUVICA is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics Switzerland GmbH. In the European Economic Area, Janssen is the marketing authorisation holder. Janssen affiliates market IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except for the United States, where both companies co-market it. 

The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 24 July 2014.² This approval allows for the marketing of IMBRUVICA in all 28 countries of the European Union.

“MCL and CLL with 17p deletion are usually challenging and difficult-to-treat blood cancers that do not respond well to conventional therapies. They usually rapidly progress during or soon after chemotherapy leaving patients with very limited treatment options and poor survival,” said Professor Peter Hillmen, Haematology, St. James’s University Hospital, Leeds, who is an investigator in the IMBRUVICA CLL clinical trial. “Being able to use IMBRUVICA as a single agent offers a new option and gives renewed hope for physicians and their patients.”

CLL in most patients is a slow-growing blood cancer, starting from white blood cells (called lymphocytes) in the bone marrow.³ The chromosomal abnormalities deletion 17p (del17p) and TP53 mutation are associated with aggressive, treatment-resistant disease.⁴ MCL is a rare and aggressive type of B-cell lymphoma that can be challenging to treat and is associated with a poor prognosis.^5,6

The approval of IMBRUVICA was based on data from the Phase 3 (RESONATE™ PCYC-1112) and Phase 1b-2 (PCYC-1102) studies in CLL, and the Phase 2 study (PCYC-1104) in MCL. 

“We are delighted the European Commission has approved IMBRUVICA as a new treatment approach, which could prolong the lives of patients with these complex blood cancers,” said Jane Griffiths, Company Group Chairman, Janssen, Europe, Middle East and Africa (EMEA). “This is a positive step forward for patients, and Janssen is committed to looking into further areas of unmet need in blood cancers where IMBRUVICA could improve outcomes.”

References

1. Akinleye A, Chen Y, Mukhi N, Song Y, Liu D. Ibrutinib and novel BTK inhibitors in clinical development. J Hematol Oncol 2013;6:59.
2. European Medicines Agency. Committee for Medicinal Products for Human Use: Summary of opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003791/WC500170191.pdf. Accessed October 2014.
3. American Cancer Society. What is chronic lymphocytic leukemia? Available at: http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll. Last accessed July 2014.
4. Schnaiter A, Stilgenbauer S. 17p Deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin N Am 2013;27:289-301.