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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 company is evaluating its investigational PKC inhibitor with Pfizer's cMET inhibitor as a treatment for metastatic uveal melanoma patients.
The companies will explore the IDE196 and Xalkori combination in solid tumors with GNAQ or GNA11 mutations, such as metastatic uveal melanoma.
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 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.