Aishi and Mercadon's potential first-line combination therapy recognized by FDA breakthrough therapy

The designation of "breakthrough therapy" is an FDA policy designed to accelerate the development and review of drugs for the treatment of serious or life-threatening diseasesTo qualify for this designation, preliminary clinical evidence must prove that the therapy may provide a substantial improvement over the currently available therapy at at least one clinically important endpointthis "breakthrough therapy" designation is based on the latest interim results of the Phase 1b trial KEYNOTE-524/116 studyThe study presented the results of the mid-term analysis of the trial at the 2019 annual meeting of the American Association for Cancer Research (AACR)the combination of the rapa is still in trial, its efficacy and safety have not yet been determined, and has not yet been approved for the treatment of any type of cancerNote: The original text has a limitationoriginal title: Aishi and Mersadon's potential first-line combination therapy is fda-recognized