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FDA Endorses Sunvozertinib for First-Line Treatment of Lung Cancer with EGFR-E20i


7 April 2024

The FDA has granted Breakthrough Therapy Designation to sunvozertinib for first-line treatment of advanced Non-Small Cell Lung Cancer with EGFR exon 20 insertion mutations. Based on promising phase I/II study results, sunvozertinib has demonstrated significant efficacy and safety, with a 78.6% response rate.

Dizal Pharma announced that the US Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to sunvozertinib as a novel treatment for lung cancer. This designation is specifically for sunvozertinib's use as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries the challenging EGFR exon 20 insertion mutations. Previously approved in China, further approvals in the U.S. and EU are anticipated.

The FDA's decision comes in light of promising data from the global multi-center phase I/II study, WU-KONG1, presented at the 2023 ESMO conference. The study highlighted sunvozertinib's effectiveness, demonstrating a confirmed objective response rate of 78.6% and a median progression-free survival of 12.4 months, marking a significant step forward in the treatment of this lung cancer subtype.

Previously, sunvozertinib received similar designations for its efficacy in treating relapsed or refractory patients, and was approved in China in 2023 for those failing first-line treatments. Further submissions for U.S. and EU approvals are anticipated in 2024, expanding its potential reach and impact.

Xiaolin Zhang, CEO of Dizal, expressed enthusiasm about the designation, noting sunvozertinib's potential to transform the treatment landscape for patients with EGFR exon20ins NSCLC. He stated, "Multiple clinical trials have consistently demonstrated sunvozertinib's significant clinical benefits to our patients. As a single, oral agent, it offers apparent advantages in both safety and patient compliance over chemotherapies and infusion."

The challenge in treating NSCLC patients with EGFR Exon20ins mutations lies in the mutation's unique structure and diversity, which has historically limited effective targeted therapy options. Sunvozertinib, with its innovative molecular design, has demonstrated the ability to overcome these challenges, offering a new hope for improved outcomes.

In China, sunvozertinib was approved for the treatment of NSCLC with EGFR exon 20 insertion mutations following platinum-based chemotherapy, based on the pivotal WU-KONG6 study. The study showed a confirmed overall response rate of 60.8%, with significant anti-tumor activity even in patients with brain metastases and various EGFR mutations.

With ongoing global studies in both second-line and first-line settings, sunvozertinib continues to be at the forefront of lung cancer research, offering new avenues for treatment. The Breakthrough Therapy Designation by the FDA not only highlights the drug's potential but also enables accelerated development and review processes, bringing it one step closer to patients in need.

About sunvozertinib (DZD9008)

Sunvozertinib, an irreversible EGFR inhibitor developed by Dizal, targets a broad range of EGFR mutations and was approved by the NMPA in August 2023 for treating advanced NSCLC with EGFR exon20ins mutations post-platinum-based chemotherapy. Based on the WU-KONG6 study's results, it showed a 60.8% confirmed overall response rate, demonstrating efficacy across various EGFR exon20ins subtypes and even in patients with brain metastases. Additionally, it has shown promise against other EGFR mutations and HER2 exon20ins mutations, with a manageable safety profile and predominantly low-grade treatment-emergent adverse events.


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