FDA
Seagen Going After Tukysa, Herceptin Combo Approval in HER2-Positive Colorectal Cancer
The company plans to seek accelerated approval for the regimen after seeing a 38 percent objective response rate in the MOUNTAINEER trial.
The agency acknowledges its staff can't keep up with the volume of cell and gene therapy products and is looking to PDUFA VII for additional funds.Â
It remains to be seen how precision oncology drug and genetic test developers will improve representation of racial and ethnic minorities based on the agency's guidelines.
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