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FDA Grants Priority Review to Dizal’s Sunvozertinib for EGFR Exon20ins NSCLC

NextEdge Admin

08 Jan 2025

2 min 44 sec

non-small cell lung cancer,Sunvozertinib,therapeutics

Dizal , a biopharmaceutical company focused on innovative cancer and immunological disease treatments, announced that the U.S. FDA has accepted and granted priority review to its New Drug Application (NDA) for sunvozertinib. This oral EGFR inhibitor targets locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins) who have progressed on or after platinum-based chemotherapy. The designation underscores sunvozertinib's potential as a significant advancement over existing treatments.

Sunvozertinib previously received FDA Breakthrough Therapy Designation in both treatment-naïve and relapsed/refractory settings. Currently, no approved small molecule drug is available in the U.S. or Europe for this indication. The NDA submission is backed by efficacy and safety data from the global pivotal WU-KONG1 Part B study, presented at ASCO 2024, which demonstrated significant clinical benefits.

"Patients with EGFR exon20ins NSCLC have poor prognoses and limited treatment options," said Dizal CEO Xiaolin Zhang, PhD. "Sunvozertinib’s Priority Review is a key regulatory milestone, and its strong clinical data highlight its potential as a safe, effective, and convenient oral therapy."

In 2023, China’s NMPA granted sunvozertinib accelerated approval, making it the first and only oral treatment for NSCLC patients with EGFR exon20ins. The drug, an irreversible EGFR inhibitor, selectively targets a broad range of EGFR mutations while sparing wild-type EGFR. It has shown promising activity against EGFR sensitizing, T790M, uncommon mutations (G719X, L861Q), and HER2 exon20ins.

Sunvozertinib demonstrated a manageable safety profile, with mostly Grade 1/2 treatment-emergent adverse events. Two pivotal global trials, WU-KONG1 (≥2nd line) and WU-KONG28 (1st line), are ongoing.

Dizal, committed to breakthrough therapeutics, has built a globally competitive portfolio, including two approved drugs and multiple late-stage assets.