Benzinga | Sep 16, 2021 06:08AM EDT

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 (NYSE: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 (NYSE: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.