OSAKA, Japan & CAMBRIDGE, Mass. - Friday, 13. January 2023 AETOSWire
– EXKIVITY is the First Category-1 Innovative Drug Approved for Takeda China Following a Phase 2 Global Pivotal Study
– Approval Based on Data from the Phase 1/2 Clinical Trial Demonstrating EXKIVITY’s Clinical Benefit and Durable Responses in EGFR Exon20 Insertion+ NSCLC
– Results Demonstrated a Confirmed Overall Response Rate (ORR) of 28% and Median Duration of Response (DoR) of 15.8 Months per Independent Review Committee (IRC)
(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that EXKIVITY® (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVIT
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