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Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations

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Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations

Shots:

  • The NMPA has designated sunvozertinib as a breakthrough therapy for the 1L treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in treatment-naive patients
  • The designation was based on combined analysis from P-I/II (WU-KONG1) & P-II (WU-KONG15) studies assessing sunvozertinib (oral) in Chinese patients, depicting a cORR of 78.6% & mPFS of 12.4mos. It is further being investigated under global P-III (WU-KONG28) trial in comparison with Pt doublet CTs for the same
  • The company also highlighted data from the part B of WU-KONG1 trial involving patients from Asia, EU, North & South America at ASCO 2024 (trial achieved its 1EP). Regulatory submissions are underway

Ref: Dizal | Image: Dizal

Related News:- Dizal's Sunvozertinib Receives the NMPA’s Approval for Non-Small Cell Lung Cancer with EGFR Exon20ins Mutations

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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