2023-07-01 11:39:56
Rexraza, developed by Yuhan Corporation, has been approved by the Ministry of Food and Drug Safety as a first-line treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Lexraza is a product approved by the Ministry of Food and Drug Safety on January 18, 2021 as a secondary treatment for EGFR T790M mutation positive. Yuhan Corporation confirmed a statistically significant improvement in progression-free survival (PFS) in a multinational phase 3 clinical trial conducted as the first-line treatment for EGFR active mutation-positive non-small cell lung cancer in October of last year. Submitted an application for domestic product approval for Lexraza as a secondary treatment.
The Ministry of Food and Drug Safety announced that, as a result of a thorough scientific review and evaluation of the data submitted by Yuhan Corporation, the scope of patients subject to the drug was expanded to “first-line treatment of patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer.”
Kim Yeol-hong, president of R&D at Yuhan Corporation, said, “With this approval, we are very pleased to be able to provide a new treatment option for patients with EGFR mutation-positive non-small cell lung cancer, which has a high prevalence in Korea.” “, as a first-line treatment, we will be able to provide more patients with high-quality drug treatment opportunities faster.”
Yuhan Corporation is currently preparing to apply for an extension of the reimbursement standard for the first-line treatment of Lexraza, and is preparing for a humanitarian level program (EAP) that provides free drugs to patients until the prescription of health insurance benefits is available. The program will proceed from the date of approval by each Institutional Review Board (IRB) until the time of the expansion of Lexraza’s salary standard.
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