Dizal Pharmaceuticals' lung cancer treatment "Zegfrovy" (ingredient name: Senbocertinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA). After China in 2023, the product is now available in the U.S. for the first time in about two years.
Dizal announced on the 2nd that Zegfrovy received accelerated approval from the FDA for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR exon 20 insertion mutation.
Lung cancer is classified as small cell lung cancer when the cancer cells are small, and as non-small cell lung cancer when they are larger. The non-small cell type accounts for 70-80% of all lung cancers.
The target of this approval is non-small cell lung cancer that has progressed after platinum-based chemotherapy, and this treatment can only be used for patients who have confirmed mutations in the 20th exon of the EGFR gene through genetic testing. The EGFR exon 20 insertion mutation is the third most common type among all EGFR mutations, and its complex structure has resulted in a low response rate to existing EGFR inhibitors.
With this approval, Zegfrovy is the first and only oral targeted therapy in the U.S. targeting the EGFR exon 20 insertion mutation.
According to the company, Zegfrovy targets a wider range of mutations compared to existing EGFR inhibitors. Previously, the FDA designated Zegfrovy as an innovative therapy eligible for priority review.
The FDA's accelerated approval is based on global phase 2 clinical study results. These study results will be presented orally at the 2024 American Society of Clinical Oncology (ASCO).
Dr. Pasi A. Jänne of Harvard Medical School's Dana-Farber Cancer Institute, who participated in the global clinical study, noted, "The EGFR exon 20 insertion mutation is a challenging mutation with limited treatment options, but Zegfrovy has shown consistent efficacy in both Asian and non-Asian patients," adding that "with daily dosing, the treatment offers convenience and adherence, making it particularly significant in the lung cancer treatment environment where chronic disease management is emphasized."
Dizal must demonstrate the clinical significance of Zegfrovy through confirmatory clinical trials to obtain formal FDA approval. The company is currently conducting global phase 3 clinical trials to expand the use of Zegfrovy as a first-line treatment for patients with EGFR exon 20 insertion mutation lung cancer.
According to interim analysis results presented at the 2023 European Society for Medical Oncology (ESMO), the objective response rate (ORR) for patients whose cancer shrank was 78.6%, and the median progression-free survival (mPFS) period during which the disease did not worsen was 12.4 months.
Zhang Xiaolin, co-founder and CEO of Dizal, stated, "Lung cancer patients with the EGFR exon 20 insertion mutation had very limited treatment options, but Zegfrovy provides a new alternative," adding that "this FDA approval is a significant milestone that reaffirms Dizal's mission to develop innovative new drugs for patients worldwide."
Dizal is a company established in Shanghai, China, through a strategic joint investment between AstraZeneca and Mirae Industries in 2017. CEO Zhang Xiaolin previously headed the 'Innovation Center China (ICC)', AstraZeneca’s R&D center in China.
Meanwhile, Yuhan Corporation's non-small cell lung cancer treatment Reklaza (ingredient name: Lazertinib), AstraZeneca's Tagrisso (ingredient name: Osimertinib), and Dizal's Zegfrovy are all oral anticancer drugs targeting EGFR mutations. However, the specific mutation types targeted and the patient groups eligible for treatment differ.