The agency recommended the drug based on the results from the Phase III ALTA-1L trial, and after Takeda agreed to offer the drug to NHS England at a discount.
The pandemic has underscored the importance of "bringing the trial to the patient," a concept that is likely to persist, particularly in precision oncology.
The positive committee opinion is based on data from the Phase III ALTA-1L trial, which is also supporting the drug's US application for a first-line indication.
The company is seeking to expand the use of the drug as a first-line treatment after it received accelerated approval from the FDA in 2017 for those who failed on Xalkori.
Data from the meeting suggest that lung cancer patients with ALK-positive tumors may soon have two first-line options and more choices when their disease progresses.
