UAE second country globally to approve a new treatment for mantle cell lymphoma

• In the UAE, approximately 4,500 new cases of cancer are reported yearly. The UAE is determined to bring down cancer fatalities by nearly 18% by the year 2021[1]
• No studies have been previously reported on the pattern of lymphoma in the UAE[2]
• Mantle cell lymphoma (MCL) is rare aggressive B-cell type of non-Hodgkin's lymphoma, and accounts for about 2%-10% of the non-Hodgkin's lymphomas[3]
• MCL has a poor prognosis with a10-year survival rate around 5%-10%[4]

United Arab Emirates: Following the accelerated approval granted by the US Food and Drug Administration (FDA) for the Mantle Cell Lymphoma (MCL) treatment, the United Arab Emirates has officially approved and registered the treatment, becoming the second country globally to introduce a new hope to rare blood cancer patients.

The treatment, provided by AstraZeneca, one of the world’s leading pharmaceutical companies, represents a milestone into the treatment of blood cancers. Blood cancers constitute a heterogeneous group of diseases of which some of them are having a generally poor survival and quality of life to patients and detrimental socioeconomic impact on healthcare systems.[5],[6]

MCL is a rare cancer of the lymphoid system that arises from the outer rim or mantle lymphoid follicle in a lymph node. The cause of MCL is unknown. Around 85% of patients have been found to have a genetic abnormality known as a translocation between chromosome 11 and 14, resulting in the overproduction of cyclin D1, a protein that drives the cell growth.[7]

In the UAE, approximately 4,500 new cases of cancer are reported yearly. In 2012, cancer was the third leading cause of deaths in the Emirate of Abu Dhabi. The UAE is determined to bring down cancer fatalities by nearly 18 % by 2021. Reducing the number of deaths due to cancer is one of the key performance indicators of the pillar of world-class healthcare of the UAE National Agenda¹¹

MCL usually combines the worst features of both high- and low-grade lymphomas, where most patients present with advanced stage and an aggressive disease, and overall survival ranges between 4 to 12 years.[8][9]

Samer Al Hallaq - Area Vice President Middle East, AstraZeneca said, “The accelerated approval of the MCL treatment is a landmark moment for AstraZeneca in the UAE as it is the second country globally after the US to grant approval on the launch of the therapy. The new treatment provides an exciting additional option for patients with MCL and marks our presence in the hematology field. In addition, it further demonstrates our commitment to scientific leadership in oncology. We pride ourselves on having been part of the fabric of the UAE for a long time. As such, we seek to provide a broad range of new therapies, as well as practical solutions to advance the care of patients, which we’re able to do now more than ever before.”

“Our primary objective is to address the unmet medical needs of people living with cancer and rare diseases. This means that we go beyond simply delivering medicines, to expanding access to them in a part of the world that presents numerous challenges. Mortality rates from cancer are increasing around the world. The Middle East region is diverse, featuring countries that struggle with cancer therapies. Despite the UAE also being part of the region, it benefits from having cutting edge therapies and comprehensive cancer care, allowing it to be at the forefront of cancer treatment in the region, added Al Hallaq.

Dr. Jorgen Kristensen, Consultant Hematologist at Mediclinic City Hospital also noted that, “The approval represents an important development for patients in the UAE and the region who are currently battling mantle cell lymphoma, which is often characterized as an aggressive type of lymphoma typically diagnosed at an advanced stage and associated with a high relapse rate. Signs and symptoms of MCL may include fever, night sweats, enlarged lymph nodes, fatigue, enlarged spleen and liver as well as weight loss[10].”

In the UAE and the wider region, AstraZeneca works healthcare systems to drive clinical trials in innovative approaches, by expanding R&D capabilities, supporting government programs and partnering with hospitals and medical centers to bring the latest innovations. This is achievable through building long-term, trusting partnerships that benefit local healthcare systems, in order to help physicians and patients.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

AstraZeneca in the Gulf

As one of the leading pharmaceutical companies in the Gulf, AstraZeneca is focused on developing innovative medicines to treat diseases in important therapy areas impacting public health. Their success is based on our commitment to serving the needs of the patients and improving their health.

AstraZeneca believes in maintaining high ethical standards of business practice. Aiming to effectively manage that responsibility, they find new ways of bringing benefit to society and thereby ensure that AstraZeneca continues to be welcomed as a valued member of the local community.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that have the potential to transform patients’ lives and the Company’s future. With at least six new medicines aimed to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

[1] The Government of the UAE | Cancer | https://government.ae/en/information-and-services/health-and-fitness/chronic-diseases-and-natural-disorders/cancer-

[2] Pattern of malignant lymphoma in the UAE | https://www.researchgate.net/publication/11683913_Pattern_of_malignant_lymphoma_in_the_United_Arab_Emirates-a_histopathologic_and_immunologic_study_in_208_native_patients

[3] Mantle Cell Lymphoma (MCL) | https://www.medicinenet.com/mantle_cell_lymphoma_mcl/article.htm#what_is_mantle_cell_lymphoma_mcl

[4] Mantle Cell Lymphoma (MCL) | https://www.medicinenet.com/mantle_cell_lymphoma_mcl/article.htm

[5] Teras, L. R. et al. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA. Cancer J. Clin. 66, 443–459 (2016)

[6] werdlow, S. H. et al. The 2016 revision of the World Health Organization classi fi cation of lymphoid neoplasms. Blood 127, 2375–2391 (2016)

[7] Mantle Cell Lymphoma (MCL) | https://www.medicinenet.com/mantle_cell_lymphoma_mcl/article.htm

[8] Mckay, P., Leach, M., Jackson, B., Robinson, S. & Rule, S. Guideline for the management of mantle cell lymphoma. 46–62 (2018). doi:10.1111/bjh.15283

[9] Ladetto, M. & Guidelines, E. Newly diagnosed and relapsed mantle cell lymphoma : ESMO Clinical Practice Guidelines for diagnosis , treatment and follow-up † Clinical Practice Guidelines. 28, 62–71 (2017)

[10] Mantle Cell Lymphoma (MCL) | https://www.medicinenet.com/mantle_cell_lymphoma_mcl/article.htm

11 https://government.ae/en/information-and-services/health-and-fitness/chronic-diseases-and-natural-disorders/cancer

© Press Release 2018