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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The CHMP opinion is based on data from a Phase I/II study of dostarlimab in mismatch repair-deficient or microsatellite instability-high endometrial cancer.

Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.

The UK's Medicines and Healthcare products Regulatory Agency approved the agent together with trastuzumab and chemo based on the Phase II HER2CLIMB trial.