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Human medicines European public assessment report (EPAR): Zykadia, ceritinib, Date of authorisation: 06/05/2015, Revision: 19, Status: Authorised

Zykadia has been shown to be effective at treating advanced, ALK-positive NSCLC in three main studies in patients whose disease progressed despite previous treatment with the medicine crizotinib:

In two of these studies, involving 303 patients, the medicine was not compared with any other treatment. Response to treatment was assessed using body scans and standardised criteria used for solid tumours, with complete response being when the patient had no remaining signs of the cancer. In one study 56% of patients given Zykadia (92 of 163) were considered by the treating doctors to have shown a complete or partial response to the medicine. The average length of response was 8.3 months. In the second study, the overall response rate was 41% (57 of 140 patients) and the average length of response was 10.6 months.

In the third study in 231 patients, Zykadia was compared with standard chemotherapy (medicines to treat cancer). Results showed that patients given Zykadia lived for an average of 5.4 months without their disease getting worse (progression-free survival) compared with 1.6 months in patients given standard chemotherapy.

Zykadia has also been shown to be effective at treating patients who had not been treated before in a study in 376 patients. Patients given Zykadia lived for an average of 16.6 months without their disease getting worse compared with 8.1 months in patients given standard chemotherapy.