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

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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.
 

Related Articles (TMO + TAK)

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Posted-In: Briefs Non-Small Cell Lung CancerBiotech News Health Care FDA General

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