Takeda’s EXKIVITY™ (Mobocertinib) Approved by U.S. FDA As First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion-Positive Non-Small Cell Lung Cancer (NSCLC); Next-Generation Sequencing (NGS) Companion Diagnostic from Thermo Fisher Scientific Approved Simultaneously

On September 15, 2021, Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and durability of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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