Takeda’s Exkivity Gets FDA OK for Some Adults With NSCLC

Takeda Pharmaceutical said the U.S FDA approved Exkivity (mobocertinib) for the treatment of some adult patients with locally advanced or metastatic non-small cell lung cancer.

• The approval covers patients with epidermal growth factor receptor exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy
• The treatment was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA
• It’s the only approved oral therapy specifically designed to target EGFR exon 20 insertion mutations
• Continued approval for this indication may be contingent upon verification and description of clinical benefit in a ...