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The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
The approval limits the drug's use to patients who are refractory or intolerant to standard-of-care treatments and contains warnings about the risk of interstitial lung disease.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
Novel clinical trials designs are enabling exploration of new precision oncology drug indications in Japan and China, and increasing patient access to treatments.
The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
The drugmaker has also submitted data on this tissue-agnostic treatment indication with US and European regulators.