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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.

The company also plans to submit a new drug application for avapritinib in mainland China in the first half of this year. 

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 Chinese drug evaluation agency has granted the investigational new drug clinical trial authorization to taletrectinib in NRTK- and ROS1-mutated cancer patients.

The drug, Amelie, will be for the second-line treatment of EGFR T790-mutated non-small cell lung cancer.