Recorded as the new drug developed in Korea No. 31
The 31st new drug developed by a domestic pharmaceutical company was born. The protagonist is Yuhan Corporation’s lung cancer treatment Rekraza® (ingredient name Razertinib), a new drug released by Yuhan Corporation for the anti-ulcer drug’Revanex’ in 2005 after 16 years.
Yuhan Corporation (CEO Jeong-hee Lee) announced that the Epidermal Growth Factor Receptor (EGFR) T790M mutation-positive non-small cell lung cancer treatment Rekraza® was approved by the Ministry of Food and Drug Safety (MFDS) on May 18.
Rekraza is an oral third-generation tyrosine kinase inhibitor (TKI) that has high selectivity for EGFR T790M-resistant mutations.
In particular, because it can cross the blood-brain-barrier (BBB), it has excellent efficacy and excellent tolerability even in lung cancer patients with brain metastases.With this permission, the EGFR T790M mutation, previously treated with EGFR TKI It can be used to treat patients with benign locally advanced or metastatic non-small cell lung cancer.
Recraza has received conditional permission for use in patients with advanced non-small cell lung cancer with positive EGFR mutations who have previously been given lung cancer treatment.
According to the data derived from patients who received lexaza as a second-line therapy in the LASER201 (YH25448-201) clinical trial, the objective response rate according to independent central review and investigator evaluation in the total dose group T790M mutation-positive patients (162 patients) was 59%. And 68%, and median progression-free survival was 10.9 months and 11.0 months. Of the patients (78) assigned to the 240 mg dose group, the objective response rates according to independent central review and investigator evaluation of T790M mutation-positive patients (76) were 58% and 72%, and the median progression-free survival was 11.0 months and 13.2. It was months.
In particular, in November 2018, Rekraza signed a technology export contract with Janssen with a total contract size of up to $1.25 billion, which is expected to have great commercial success. This is a scale that ranks fifth in history among new drugs exported by domestic pharmaceutical companies.
Professor Ahn Myung-joo of the Department of Hematology and Oncology, Samsung Medical Center said, “Recraza is the first new drug developed in Korea to be published in the world-renowned journal, Lancet Oncology, and has been recognized for its efficacy and safety. “This approval is expected to be a suitable treatment option for non-small cell lung cancer patients with positive EGFR T790M mutations.” Professor Ahn Myung-Joo is the first author of the clinical thesis behind the approval.
Professor Cho Byeong-cheol, director of the Lung Cancer Center at Yonsei Cancer Hospital, said, “The domestic approval of Rekraza has great implications.” “It will be a good treatment alternative for Korean lung cancer patients through clinically meaningful anti-tumor effects and safety. It is expected to be the hope of lung cancer patients around the world.” Professor Byeong-cheol Cho leads the licensed clinical trials of Rekraza and leads the study of multinational phase 3 clinical trials.
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