CHMP recommends extension of Xgeva indication to treat giant cell tumour of the bone-- Amgen.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xgeva. The marketing authorisation holder for this medicinal product is Amgen Europe B.V. The CHMP adopted an extension to an existing indication as follows : �Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours advanced malignancies involving bone .� For information, the full indications for Xgeva will be as follows: �Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.