The Committee for Medicinal Products for Human Use (CHMP) decided that TORISEL’ s benefits are greater than its risks for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of the following prognostic risk factors: • less than one year from time of initial renal cell carcinoma diagnosis, • Karnofsky score status of less than 70, • haemoglobin less than the lower limit of normal, • corrected calcium of greater than 10 mg/ dl, • lactate dehydrogenase over 1.5 times the upper limit of normal, • more than one metastatic organ site.