[Beijing], [30 August, 2017] – Xian Janssen Pharmaceutical Ltd. announced today that the China Food and Drug Administration (CFDA) has approved IMBRUVICA® (ibrutinib) capsules as a monotherapy for adult patients with chronic lymphocytic leukaemia (CLL), including small lymphocytc lymphoma (SLL), and for the treatment of patients with mantle cell lymphoma (MCL), who have received at least one prior therapy.
IMBRUVICA® was granted Priority Review by the Center for Drug Evaluation (CDE), CFDA in December 2016. The CDE CFDA designates Priority Review to certain medicines based on the clinical benefit and the high unmet treatment need. The Priority Review in China and in other countries including the United States, reinforces the unprecedented clinical benefits seen with IMBRUVICA treatment in these types of blood cancers.
CLL is a slow-growing type of blood cancer that affects the development of white blood cells, called B-lymphocytes, (commonly known as B cells). CLL and SLL are essentially the same disease: when most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.[1]
MCL is an aggressive form of blood cancer which originates from B cells, a type of white blood cell (lymphocyte) and although it typically involves the lymph nodes, it can spread to other tissues, such as the bone marrow and liver.[2],[3],[4]
Until now treatment options for these patients has been limited to chemotherapy and in the case of CLL/SLL, the overall survival is always less than two to three years if the disease returns[5]. Patients with MCL temporary respond to chemotherapy and, due to a high recurrence rate, their long-term prognosis is poor.[6] The median overall survival for MCL is typically three to four years, and only one to two years following the first relapse.[7]
“Although chemotherapy is an effective treatment option, most patients inevitably developed drug resistance and relapsed, resulting in poor prognosis and unmet medical needs. Therefore, patients with CLL / SLL and MCL in China are in urgent need of innovation of more effective treatment options,” said Professor Ma Jun, Director of the Hematology & Oncology Hospital of Harbin Medical University. “Global researches have shown that ibrutinib is well tolerated and can significantly reduce the disease progression and the risk of death in patients. Furthermore, ibrutinib is convenient and simple to take with oral, once-daily dosing, which helps improve life quality. The approval of IMBRUVICA®, the new molecular targeted drug, will offer patients with CLL/SLL and MCL a well-tolerated and effective alternative, and will become a great breakthrough in the treatment of B cell blood cancer in China.”
“The clinical and real-world evidence in support for patient benefits of ibrutinib continues to be reinforced world-wide,” said Asgar Rangoonwala, President of Xian Janssen Pharmaceuticals Ltd. “We are pleased with the approval of IMBRUVICA in China as this is a positive step forward in addressing the unmet needs of Chinese patients with these blood cancers and we continue our commitment in exploring other areas of unmet need to help prolong and improve patient lives.
IMBRUVICA® was co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Xian Janssen will commercialize IMBRUVICA® in China, and Janssen operating companies are commercializing it around the world, except for in the United States, where Pharmacyclics, LLC and Janssen Biotech Inc. co-market IMBRUVICA®.
IMBRUVICA® is approved in 85 countries, and has been used to treat more than 75,000 patients world-wide. In 2015, IMBRUVICA® (ibrutinib) was awarded the prestigious Prix Galien USA 2015 Award in the category of Best Pharmaceutical Agent[8].
About CLL/SLL
CLL is a rare, hard-to-treat B-cell malignancy that is associated with poor prognosis, especially when patients fail or don’t respond to other first line therapies. Despite the availability of effective first line chemo-immunotherapy regimens for CLL, many patients, especially the elderly, cannot tolerate their adverse effects.[9] CLL is a chronic disease with an overall five-year survival rate of 78 percent,[10] but it remains an incurable disease. Treatments available generally induce remission, however the disease returns in nearly all patients and up to 70 percent of the patients will need treatment for their disease at some stage. CLL and SLL are the same disease, the only difference is where the cancer occurs. When most of the cancer cells are located in the bloodstream or bone marrow, the disease is referred to as CLL. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL.
About MCL
MCL is an incurable disease predominantly found in the elderly male population. The disease is associated with rapid progression, has only temporary responses to chemotherapy and is of a high recurrence rate, resulting in a poor long-term prognosis.[11] MCL patients generally have a poor prognosis: median overall survival is typically three to four years, and only one to two years following the first relapse.[12]
2. Leukemia and Lymphoma Society. Mantle Cell Lymphoma Facts. Available from:
http://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf.Accessed January 2015.
3. Cancer Research UK. What is mantle cell lymphoma. Available from: http://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/mantle-cell?_ga=2.120916813.45843779.1502692742-668074634.1496287210. Accessed January 2015.
4. MacMillan Cancer Support. Mantle cell lymphoma. Available from:
http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Lymphomanon-Hodgkin/TypesofNHL/Mantlecell.aspx. Accessed January 2015.
5. Stilgenbauer S, Zenz T. Understanding and managing ultra high-risk chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2010;2010:481-8.
6. Herrmann A, Hoster E, Zwingers T, Brittinger G, Engelhard M, Meusers P, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27(4):511–8.
7. Goy A, Bernstein SH, Kahl BS, et al. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol 2009:20:520–5.
8. IMBRUVICA® (ibrutinib) Awarded Prix Galien 2015 Best Pharmaceutical Agent. Available at: http://www.janssen.com/imbruvica-ibrutinib-awarded-prix-galien-2015-best-pharmaceutical-agent.
9. O’Brien SM, Furman RR, Byrd JC. Unmet needs in the treatment of chronic lymphocytic leukemia: integrating a targeted approach. Clin Adv Hematol Oncol. 2014;12(1, Suppl.3):1-13.
10. Cancer Research UK. Statistics and outlook for chronic lymphocytic leukaemia. Available at: http://www.cancerresearchuk.org/cancer-help/type/cll/treatment/statistics-and-outlook-for-chronic-lymphocytic-leukaemia Last accessed July 10, 2014.
11. Herrmann A, Hoster E, Zwingers T, Brittinger G, Engelhard M, Meusers P, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27(4):511–8.
12. Goy A, Bernstein SH, Kahl BS, et al. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol 2009:20:520–5.