美国安进地舒单抗注射液适应症有哪些

On May 27, 2019, Amgen China announced that it had been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

As the manufacturer of denosumab, Amgen Biopharmaceutical Company (Amgen) is the world's leading innovative biopharmaceutical R&D and production company and one of the largest biopharmaceutical companies in the world. The company was founded by scientist George B. It was co-founded in 1980 by Dr. Rathmann, Dr. Joseph Rubinfeld and other venture capitalists. It takes "drug innovation" as its core concept and attaches great importance to the accumulation of R&D capabilities. It has achieved major breakthroughs in the fields of human genome, tumor biology, neuroscience, hematology and other fields.

In 2018, denosumab was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the rapid review channel of the National Medical Products Administration. This approval makes denosumab the first and currently the only drug in China for the treatment of giant cell tumor of bone, bringing patients an innovative treatment option to control disease progression and improve quality of life.

The approval of denosumab is based on the results of two open-label trials in patients with recurrent, unresectable giant cell tumor of bone or in whom planned surgical resection is likely to cause severe functional disability. The latest analysis of the study, presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2017, showed that among patients who could be surgically resected, 80% improved after receiving neoadjuvant denosumab: 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.

Tell your doctor right away if a patient develops any of these symptoms while receiving denosumab or after stopping treatment, pain in the mouth and/or jaw, swelling or non-healing sores in the mouth and/or jaw, swelling or loosening of teeth in the mouth and/or jaw, non-healing sores in the mouth or jaw, discharge, numbness, or heaviness, which may be a sign of damage to the jawbone (osteonecrosis).

Rare side effects: allergic reaction (such as difficulty breathing or breathing, swelling of the face, lips, tongue, throat, or other parts of the body, rash, itching, or hives). In rare cases, allergic reactions can be serious. New or unusual hip, groin, or thigh pain (this may be an early sign of a possible femur fracture).

The above is the indications and related introduction, I hope it can help you.

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