Saturday, June 22, 2024

A Leap Forward in Lung Cancer Treatment with EGFR Mutations: Sunvozertinib Secures FDA Breakthrough Designation

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Dizal revealed today that sunvozertinib has received a Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its use as a primary treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The BTD was awarded following the promising results from the WU-KONG1 global multi-center phase I/II study, presented at the 2023 ESMO conference. The study demonstrated a confirmed objective response rate (cORR) of 78.6% and median progression-free survival (mPFS) of 12.4 months for sunvozertinib as a monotherapy.

Previously, sunvozertinib was granted BTDs in the US and China for its use in treating relapsed or refractory patients and received approval in China in 2023 for patients who failed first-line treatments. Further applications for approval in the US and EU are expected later this year.

FDA’s Breakthrough Therapy Designation for Sunvozertinib Ushers in a New Era for First-Line Lung Cancer Treatment

“We are thrilled about the FDA’s decision to grant BTD for sunvozertinib as a first-line treatment. This marks a significant milestone following its earlier approval for later lines of therapy. Sunvozertinib’s substantial clinical benefits have been consistently demonstrated across multiple trials. Its single, oral formulation offers clear advantages in safety and patient compliance over traditional chemotherapies,” stated Xiaolin Zhang, PhD, CEO of Dizal.

“With the global pivotal study (WU-KONG1 PART B) enrollment complete, we anticipate presenting the results at the 2024 ASCO Annual Meeting. A phase III study (WU-KONG28) is also in progress to further establish sunvozertinib in the first-line treatment setting. This BTD accelerates our efforts with the FDA to advance its clinical development and regulatory submission.”

EGFR Exon20ins mutations, affecting about 2%-4% of non-small cell lung cancer patients, present unique challenges for treatment due to their specific characteristics and high variability. Sunvozertinib’s novel molecular design targets these mutations effectively, demonstrating significant efficacy, safety, and ease of use. Following a pivotal phase 2 study (WU-KONG6), sunvozertinib was approved in China for treating adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations post-platinum-based chemotherapy.

Lung Cancer

A Milestone in EGFR-Targeted Lung Cancer Treatment, Spotlighted by FDA’s Breakthrough Designation

The FDA’s Breakthrough Therapy Designation expedites the development and review of drugs treating serious or life-threatening conditions, where preliminary clinical evidence shows a substantial improvement over existing therapies. Drugs with BTD benefit from FDA guidance throughout the clinical development process and may receive priority review upon marketing application submission.

Sunvozertinib, discovered by Dizal scientists, is an irreversible EGFR inhibitor that targets a broad spectrum of EGFR mutations with selectivity. Its approval by the NMPA in August 2023 for treating advanced non-small cell lung cancer with EGFR exon20ins mutations post-platinum-based chemotherapy underscores its potential.

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The WU-KONG6 study’s results supported this approval, showing a 60.8% confirmed overall response rate (cORR). Sunvozertinib also exhibits promising anti-tumor activity in various NSCLC patients, including those with brain metastasis and other EGFR and HER2 mutations, while maintaining a manageable safety profile.


Resource: Dizal Pharmaceutical, April 07, 2024

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