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 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.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The study combined large-scale protein post-translational modification datasets with protein-protein interaction data to profile cell signaling in lung cancer.
