You may find more results for this query on our sister sites: GenomeWeb and 360Dx.
News and reporting on ALK biomarkers.
The test will be used in the trial to improve understanding of molecular resistance mechanisms to Pfizer's Lorviqua and other ALK inhibitors.
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 study is evaluating the drug in previously treated NSCLC patients with alterations in EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET.
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 studies will evaluate Lorbrena in patients with newly diagnosed, high-risk neuroblastoma whose tumors harbor an ALK gene mutation.
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.