Exkivity®

(mobocertinib)^1-3 Takeda

• Mobocertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR) that selectively inhibits and irreversibly binds to EGFR exon 20 insertion mutations at lower concentrations than Wild type (WT)-EGFR.

• The US Food and Drug Administration (FDA) granted mobocertinib an accelerated approval in 2021 to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

References:

1. EXKIVITY 40 mg hard capsules. EMC. Published 2023. Accessed May12, 2023. https://www.medicines.org.uk/emc/product/13468/smpc#gref  

2. EXKIVITY (mobocertinib) capsules. FDA. Published 2021. Accessed May15, 2023. chrome- extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215310s000lbl.pdf 

3. FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. Published 2021. Accessed May15, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mobocertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20