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AMGEN RECEIVES APPROVAL FOR XGEVA®(DENOSUMAB) IN CHINA AS THE FIRST MEDICINE TO TREAT GIANT CELL TUMOR OF BONES (GCTB)

News Releases
May 24, 2019

Amgen Receives Approval For XGEVA®(Denosumab) in China As The First Medicine To Treat Giant Cell Tumor Of Bones (GCTB)

SHANGHAI, CHINA (May 24th, 2019) —— Amgen China today announced that XGEVA® (denosumab) Injection has been approved by the National Medical Products Administration (NMPA) for the treatment of adults and skeletally mature adolescents (defined as having at least one mature long bone and weigh≥45 kg) with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. In 2018, XGEVA® was included in the list of Overseas Approved New Drugs in Clinically Urgent Needs (1st batch) and entered the NMPA’s Priority Review channel1. This approval has enabled XGEVA®to be the first and only approved medicine for GCTB, providing a novel treatment choice for patients to control the progression of the disease, facilitate surgical treatment and improve quality of life.

GCTB is a mostly benign, but often aggressive bone tumor2 afflicting younger adults between the ages 20 to 403. It has a higher incidence rate in females, which is about 56.4%3. Globally, GCTB accounts for approximately 4%-5% of primary bone tumors4 and is comparatively more common in China than in the U.S. and European countries. It is estimated that GCTB occupies 20% of primary bone tumors5 in China. Although most GCTB tumors are benign, they often result in the complete destruction of the affected bone, leading to bone fracture, joint dysfunction or amputation, if not diagnosed timely and treated properly.

Giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor. Excess RANK Ligand (RANKL) has been implicated in giant cell tumor pathogenesis impacting tumor growth and bone destruction.6 RANKL is a protein essential for the formation, function, and survival of osteoclasts - the cells responsible for bone resorption and thus regulates calcium release from the bone. XGEVA® is a fully human monoclonal immunoglobulin G2 antibody with high specificity and affinity for RANKL. Signaling through the RANK receptor contributes to osteolysis and tumor growth. XGEVA® binds to RANKL and prevents it from activating its receptor, RANK, on the surface of osteoclasts, their precursors and osteoclast-like giant cells, consequently controlling the growth of tumors and reducing bone destruction.

Prof. Niu Xiaohui, Director of the Orthopaedic Oncology Department at the Beijing Jishuitan Hospital, and President of the Osteosarcoma Committee of Chinese Society of Clinical Oncology (CSCO), said, “According to a research report on GCTB epidemiology in China, it is estimated that its incidence ranges between 1.49 and 2.57 cases per million people per year, which means it is quite uncommon7. Current treatments are mainly surgery and radiotherapy. Surgery is the primary treatment for GCTB, but with a high recurrence rate of 15%~45%8,9 after the curettage according to different studies. While radiotherapy can control the growth of the tumor to a certain degree, it can also induce complications and potential risks of sarcomatoid malignancy. Until now, there was no effective medicine approved in China for patients with GCTB that is unresectable or where surgical resection results in severe morbidity. The approval of denosumab signifies that the innovative therapy long-awaited by patients with GCTB has finally arrived. Its dual effects of inhibiting tumor growth and reducing bone damage, as well as the good tolerance, will bring clinical benefits to patients and improve their quality of life.”

The approval of XGEVA® is based on positive results from two open-label trials that enrolled patients with GCTB that was either recurrent, unresectable, or for which planned surgery was likely to result in severe morbidity. The latest analysis of one of the studies announced at the 2017 ESMO (European Society for Medical Oncology) annual meeting showed that the overall response rate of the patient with resectable GCTB after denosumab treatment was 80%; 44% of patients who had surgery underwent a less morbid procedure; and 37% of patients required no surgery. Denosumab brings effective long-term disease control benefits to patients with unresectable GCTB with a 5-year PFS (progression-free survival) rate of 88%.10

“As the first and only approved medicine for GCTB in China, XGEVA® is of great significance for patients who suffer from this uncommon disease, especially for those with unresectable GCTB or where surgical resection is likely to result in severe morbidity,“ said Penny Wan, Head and General Manager of Amgen’s Japan and Asia Pacific Region. “Meanwhile, XGEVA® is the first oncology medicine that Amgen brings for Chinese patients which will also inject new power for our development in China and lay the foundation for the exploration in the field of tumor treatment. With our mission of serving patients, we are committed to making efforts in the field of severe diseases. In the future, Amgen will bring more innovative therapies for Chinese patients and contribute to the ‘Healthy China’ initiative.”

XGEVA® has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC).

About Giant Cell Tumor of Bone (GCTB)

GCTB is a locally aggressive, benign tumor afflicting younger adults between the ages 20 to 403. It is estimated that GCTB occupies approximately 20% of primary bone tumor in China5.

Most tumors occur in the long bones of the body, but can also spread to the lungs in rare cases. Although giant cell tumors are slow growing, patients can experience severe bone pain, swelling, loss of mobility and pathologic fracture. Before the approval of XGEVA®, there have been no approved therapies for GCTB. Surgery is the main treatment option for patients with resectable GCTB; however, some patients need to receive surgery, such as joint resection and amputation, which is associated with significant morbidity. Part of patients will experience recurrence after the first surgery. When tumors recur, they become more difficult to treat and more likely to spread to other parts of the body.

About XGEVA®

XGEVA® (Denosumab Injection) is a fully human monoclonal immunoglobulin G2 antibody.

XGEVA binds to RANK Ligand (RANKL), a protein essential for the formation, function and survival of osteoclasts - the cells responsible for bone resorption and thus regulates calcium release from the bone. Similarly, Giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor. Signaling through the RANK receptor contributes to osteolysis and tumor growth. XGEVA prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors and osteoclast-like giant cells.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen established an affiliate in China in 2012, and has since opened its China Headquarters and Asia Research & Development Center in Shanghai. Amgen also has an office in Beijing, which is responsible for drug registration and clinical trials, with the aim to deliver its medicines to patients in China. For more information, visit www.amgen.cn.

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