Therapeutic Response

EGFR Exon 20 (Insertion) status confers therapeutic sensitivity to Mobocertinib in patients with Non-Small Cell Lung Cancer.

Statements

Source and description

Exkivity (mobocertinib) [package insert]. FDA. 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).