Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Mobocertinib in patients with Non-Small Cell Lung Cancer.
The U.S. Food and Drug Administration granted accelerated approval to mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
This statement is based on a regulatory approval from the Food and Drug Administration:
EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).