Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 >= 1%, Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Ipilimumab, Nivolumab in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted approval to ipilimumab in combination with nivolumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
This statement is based on a regulatory approval from the Food and Drug Administration:
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (>=1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab.