A New Therapy Available in Lebanon for Treatment of Men with Metastatic Castration-Resistant Prostate Cancer

Prof. Fadi Farhat, President of Lebanese Oncology Society and Head of Hematology & Oncology at Hammoud Hospital UMC, Beirut, said: “The scientific community’s battle with cancer is ongoing. Prostate cancer is among the most common diseases threatening men of older age groups. As a consequence of late diagnosis, it is often the case that men who suffer from the disease are incurable. Relapse following conventional treatment is also problematic.”

“Treatment of prostate cancer depends on factors including malignancy and expansion of the disease. Hormone therapy is considered fundamental in the treatment of advanced and extensive prostate cancer. This treatment deprives the disease of the male hormone that feeds it, so the tumor shrinks and diminishes. In most cases the response to traditional hormone therapy is temporary and lasts for about two years, after which hormone therapy alone becomes insufficient for controlling the disease. Palliative therapy is generally used to treat extensive cancer that is non-responsive to traditional hormone therapy, offering the patient extended survival and reduced pain”, commented Prof. Muhammed Bulbul, Clinical Professor of Surgery at the American University of Beirut Medical Center.

“This new medication available in Lebanon will improve the survival time of patients suffering from metastatic prostate cancer by several months, as well as improving the patient’s quality of life. Importantly, such drugs can be administered at home, avoiding hospitalisation of the patient and the need for aggressive or intrusive medical procedures. This is, needless to say, an important development for oncology in Lebanon” continued Prof. Farhat.

Enzalutamide is an androgen receptor signalling inhibitor that reduces prostate specific antigen serum levels after a month of taking the medicine. The treatment delays the need for chemotherapy, and allows longer and better quality of life for patients suffering from the disease.4

The safety and effectiveness of enzalutamide was evaluated in a study of 1,199 patients with mCRPC.5 The study was designed to measure overall survival (the length of time before death) in men receiving enzalutamide compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving enzalutamide was 18.4 months, compared with 13.6 months for the patients who received placebo, representing an advantage of 4.8 months.1

Commenting on Astellas’ presence in Lebanon, Mr. Markus Weber, General Manager Astellas Pharma MENA/SSA, said: “As a leading research-driven pharmaceutical company, we are committed to bringing innovative treatment options and to raising awareness about prostate cancer in Lebanon and the Middle East. We look forward to collaborating with Lebanon’s medical community to help combat prostate cancer among men, to improve survival rates and to enhance quality of life.”

References

1. Scher H I, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy - N Engl J Med 2012; 367:1187-1197September 27, 2012DOI: 10.1056/NEJMoa1207506
2. Globocan
3. Xtandi™ 40mg soft capsules, enzalutamide; Package leaflet - information for the patient
4. Evidence for the efficacy of enzalutamide in postchemotherapy metastatic castrate-resistant prostate cancer, National Center for Biotechnology Information
5. FDA approves new treatment for a type of late stage prostate cancer

About Astellas Pharma Inc.

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as its prioritised therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also exploring to create new values by combining internal capabilities and external expertise in medical/healthcare business. Astellas stays on the forefront of healthcare change and turn innovative science into values for patients. For more information, please visit our website at www.astellas.com/en.

About Astellas MENA/SSA

Astellas MENA/SSA is an affiliate of Astellas Pharma Inc. and aims to make a positive difference to the patients in the Middle East & Africa region, which is a key territory for Astellas. The new regional affiliate in Dubai, United Arab Emirates brings together a team of highly skilled people, with local knowledge and long-standing professional experience in the region. The regional affiliate serves as a management hub to further expand and develop Astellas’ business activities across the MENA/SSA region.

About the Medivation/Astellas Collaboration

In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialise enzalutamide. The companies are collaborating on a comprehensive development programme that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as breast cancer. The companies jointly commercialise enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercialising enzalutamide outside the U.S.

About enzalutamide

Enzalutamide is a novel, oral, once-daily androgen receptor signaling inhibitor. Enzalutamide directly targets the androgen receptors (AR) and exerts its effects on all three steps of AR signaling pathway:
• Blocks androgen binding1
o Androgen binding induces a conformational change that triggers activation of the receptor2
• Prevents nuclear translocation1
o Transit of the AR to the nucleus is an essential step in AR-mediated gene regulation2
• Impairs DNA binding1
o Binding of the AR to the DNA is essential for modulation of gene expression2

Enzalutamide was first approved by the European Commission in June 2013 for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.3 Enzalutamide is now approved in Europe for the treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.3

Important Safety Information for enzalutamide
For important Safety Information for enzalutamide please see the full Summary of Product Characteristics at: http://www.medicines.org.uk/emc/medicine/27912/SPC/Xtandi+40mg+soft+capsules/.

References

1. Tran C, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009; 324:787-790
2. Hu R, Denmeade SR and Luo J. Molecular processes leading to aberrant androgen receptor signaling and castration resistance in prostate cancer. Expert Rev Endocrinol Metab 2010; 5 (5): 753–764
3. European Medicines Agency. XTANDI (enzalutamide). Summary of Product Characteristics, 2015