Takeda's Exkivity Scores FDA Nod As First Oral Therapy For Lung Cancer With EGFR Exon20 Insertion

The FDA has approved Takeda Pharmaceutical Co Ltd's TAK Exkivity (mobocertinib) for non-small cell lung cancer (NSCLC) settings.
The approval comes for adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
Exkivity is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations, Takeda says.
The indication is approved under Accelerated Approval based on Phase 1/2 trial results, which demonstrated clinically meaningful responses with a median duration of response (DoR) of approximately 1.5 years.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA simultaneously approved Thermo Fisher Scientific Inc's TMO Oncomine Dx Target Test as an NGS companion diagnostic for Exkivity.
Related content: Benzinga's Full FDA Calendar.
Price Action: TAK stock closed 1.49% higher at $17.00 on Wednesday.