Indications of Mobocertinib

Exkivity is 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).

from FDA，2023.09