Dizal Seeks US FDA Approval for Sunvozertinib to Treat Relapsed or Refractory NSCLC

Dizal Seeks US FDA Approval for Sunvozertinib to Treat Relapsed or Refractory NSCLC

By, Admin 11 November 2024

Dizal seeks US FDA approval for sunvozertinib to treat relapsed or refractory NSCLC with EGFR Exon 20 insertion mutations

Overview

Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

Accelerated Approval: Sunvozertinib

  • Previously, sunvozertinib received accelerated approval in China, making it the world’s first and only oral drug for NSCLC patients with EGFR exon20ins. 
  • It has also been granted Breakthrough Therapy Designations (BTDs) by both the US FDA and the China Center for Drug Evaluation (CDE) for treating EGFR exon20ins NSCLC.

WU-KONG1 Part B Study: Behind the submission

  • The submission is supported by results from the WU-KONG1 Part B study, a multinational pivotal study investigating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients from Asia, Europe, North America, and South America. 
  • Sunvozertinib met the primary endpoint by demonstrating statistically significant and clinically meaningful objective response rate (ORR), as assessed by an independent review committee (IRC), while maintaining a manageable safety profile. 
  • Data from the study were presented in an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Words from the CEO: Dizal

  • We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC.” said Xiaolin Zhang, PhD, CEO of Dizal. 
  • The filing for approval of sunvozertinib marks Dizal’s first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application.

About Lung Cancer

  • Lung cancer is the leading cause of cancer incidence and mortality worldwide. NSCLC accounts for approximately 80%-85% of all lung cancers. 
  • Patients with NSCLC harbouring EGFR exon20ins are reported to have poorer prognosis than those with other EGFR sensitizing mutations. 
  • Sunvozertinib, with its innovatively designed molecular structure, provides enhanced efficacy, safety, and ease of administration.

About the Drug: Sunvozertinib

  • Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. 
  • In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. 
  • The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. 
  • The primary endpoint of the study was the confirmed overall response rate (cORR) as assessed by the Independent Review Committee (IRC) reached 60.8%. 
  • Anti-tumour efficacy was observed across a broad range of EGFR exon20ins subtypes, and in patients with pretreated and stable brain metastasis. 
  • In addition, sunvozertinib also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.
  • Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. 
  • The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Gobal Pivotal Studies

Two global pivotal studies are ongoing in = 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Published in Article

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.

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