[이데일리 신민준 기자] Yuhan Corporation (000100) announced that it had received item approval from the Ministry of Food and Drug Safety for Lexraza (ingredient name: Lazertinib mesylate monohydrate) as a first-line treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) 30 the day said Rexraza (tablets) 80mg. (Photo = Yuhan Corporation) 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 in a multinational phase 3 clinical trial conducted as the first-line treatment for EGFR activating mutation-positive non-small cell lung cancer in October of last year. In March of this year, Yuhan submitted an application for domestic approval of Rexraza as the first-line treatment for EGFR mutation-positive patients.
Kim Yeol-hong, president of R&D at Yuhan Corporation, said, “Rexraza is a drug that was created through Yuhan’s scientific capabilities and ceaseless efforts. 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,” he said. We will be able to provide drug treatment opportunities faster.”
Meanwhile, Yuhan Corp. is preparing to apply for an expansion of the reimbursement standard for the first-line treatment of Lexraza. Yuhan Corporation is also preparing a humanitarian program to provide free medicines to patients until they can receive health insurance benefits. 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.
2023-06-30 07:51:45
#Yuhan #Corporation #obtains #approval #Ministry #Food #Drug #Safety #firstline #nonsmall #cell #lung #cancer #treatment #Lexraza
