1.1 Entrectinib is recommended, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors. It is recommended only if the company provides entrectinib according to the commercial arrangement.
Why the committee made these recommendations
Evidence for entrectinib in ROS1-positive advanced NSCLC comes from a small study that did not compare entrectinib with anything else. It includes mostly people with previously treated disease. The evidence suggests that entrectinib is effective at shrinking tumours and slowing disease progression.
Two indirect comparisons of entrectinib, using evidence from a different kind of NSCLC, show that it is clinically effective compared with pemetrexed and platinum chemotherapy. But because the evidence is from a different population, this is uncertain.