Crizotinib (4) – Xalkori®

• Clinical trials
  • Both RCTs compare crizotinib with chemotherapy in previously untreated (PROFILE1014) and previously treated (PROFILE1007) patients with ALK-positive advanced NSCLC and have already been assessed for these patients.

1) previously untreated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC)

• For previously untreated patients with ROS1-positive, advanced non-small cell lung cancer and previously treated patients with ROS1-positive, advanced non-small cell lung cancer who are eligible for treatment with docetaxel or pemetrexed, an additional benefit over the appropriate comparator therapy is not proven.
• There are no randomised controlled trials (RCTs) involving patients with ROS1-positive advanced NSCLC that directly compare crizotinib with the appropriate comparator therapy.
• Overall, there are no data available that would allow an assessment of the additional benefit of crizotinib compared with the appropriate comparator therapy. The additional benefit is not proven.

2a) Previously treated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) – patients for whom treatment with docetaxel or pemetrexed is an option

• For previously untreated patients with ROS1-positive, advanced non-small cell lung cancer and previously treated patients with ROS1-positive, advanced non-small cell lung cancer, for whom treatment with docetaxel or pemetrexed is an option, an additional benefit over the appropriate comparator therapy is not proven.
• There are no randomised controlled trials (RCTs) involving patients with ROS1-positive advanced NSCLC that directly compare crizotinib with the appropriate comparator therapy.
• Overall, there are no data available that would allow an assessment of the additional benefit of crizotinib compared with the appropriate comparator therapy. The additional benefit is not proven.

2b) Pre-treated patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) – patients for whom treatment with docetaxel or pemetrexed is not an option

• For previously treated patients with ROS1-positive, advanced non-small cell lung cancer for whom treatment with docetaxel or pemetrexed is not an option, an additional benefit is not proven compared with the appropriate comparator therapy.
• The pharmaceutical manufacturer has not submitted any data on this issue.

Courtesy translation only, please refer to the German original.