Dizal announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to its drug sunvozertinib as the primary treatment for patients diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

This significant milestone follows the results from the global multi-center phase I/II study (WU-KONG1), which were presented at the 2023 ESMO conference. The study demonstrated sunvozertinib's effectiveness as a standalone treatment, achieving a confirmed objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months.

Sunvozertinib had previously received BTDs from both the US FDA and the China Center for Drug Evaluation (CDE) for patients with relapsed or refractory conditions. It was approved in China in 2023 for patients failing initial treatment, with anticipated NDA submissions for US and EU approvals in the same context expected later in 2024.

"We are pleased with the FDA's decision to grant Breakthrough Therapy Designation to sunvozertinib for first-line treatment, following earlier BTD approval for subsequent lines of therapy," said Xiaolin Zhang, PhD, CEO of Dizal. "Numerous clinical trials have consistently demonstrated sunvozertinib's significant clinical advantages for patients with EGFR exon20ins NSCLC."

EGFR Exon20ins mutations affect roughly 2%-4% of NSCLC patients and have posed treatment challenges. Sunvozertinib's innovative molecular structure overcomes these challenges, offering improved efficacy, safety, and ease of administration. Supported by findings from the WU-KONG6 study, it was approved in China for treating NSCLC patients with EGFR exon 20 insertion mutations post-platinum-based chemotherapy.

Breakthrough Therapy Designation by the FDA is intended to expedite the development and review of drugs for serious or life-threatening conditions. Sunvozertinib (DZD9008) is an irreversible EGFR inhibitor discovered by Dizal scientists, showing promising results in clinical trials and holding potential as a significant advancement in the treatment of NSCLC patients with EGFR Exon20ins mutations.

 

Source: prnewswire.com

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