Takeda Racks Up Designations for Rare Lung Cancer Drug

The U.S. Food and Drug Administration (FDA) today awarded a number of approvals for Takeda Pharmaceutical’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer. 

Takeda was granted priority review and received a Breakthrough Therapy designation, Fast Track designation, and Orphan Drug designation, as the first and only approved oral therapy designed to target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. EXKIVITY, also called mobocertinib, is a first-in-class oral tyrosine kinase inhibitor (TKI) indicated for NSCLC cases that have progressed on or after platinum-based chemotherapy. 

Patients with EGFR Exon20+ NSCLC make up around one to two percent of patients, and the disease is more common in Asian populations than in Western communities. It carries a worse prognosis compared to other EGFR mutations and current chemotherapy interventions provide little to no benefit. 

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