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News and reporting on ALK biomarkers.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
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 drug developer will submit a new drug application with the FDA based on the Phase III study results presented at a medical conference last week.
The company said that the third-generation TKI achieved its primary endpoint of improved progression-free survival versus Xalkori in a Phase III trial.
Despite recognition among drugmakers, researchers, and regulators of the need to diversify precision oncology trials, few Black and Hispanic patients are included in studies.
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.
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.