The agency approved the drug based on a study that showed an 88 percent response rate in young patients with ALK-positive anaplastic large cell lymphoma.
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 data may result in another option for patients in the crowded first-line ALK-positive lung cancer market, though progression-free survival data are not yet mature.
The pandemic has underscored the importance of "bringing the trial to the patient," a concept that is likely to persist, particularly in precision oncology.
However, the lack of biomarker-specific treatment data kept researchers from definitively concluding that precision oncology treatments were behind an accelerated rate of NSCLC mortality decline.
