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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The approval is supported by a randomized trial showing that pembrolizumab nearly doubled progression-free survival compared to the standard chemotherapy regimen.

Healthcare professionals can inject the regimen, containing Perjeta, Herceptin, and hyaluronidase, in patients' homes after intravenous chemotherapy.

The agent has been approved for both treatment-naïve and previously treated patients whose tumors have a mutation that leads to MET exon 14 skipping.

The committee recommended the tumor-agnostic drug for use in the Cancer Drugs Fund while awaiting mature survival data from ongoing clinical trials.

Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.