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Registered as a new drug developed in Korea No. 31, conditionally approved as a second-line treatment for lung cancer
The 31st new drug developed by a national pharmaceutical company was born. The protagonist is Yuhan Corporation’s lung cancer treatment Rekraza® (ingredient name Razertinib), a new drug launched by Yuhan Corporation for the antiulcer drug ‘Revanex’ in 2005 after 16 years.
Yuhan Corporation (CEO Jeong-hee Lee) announced that the treatment for epidermal growth factor receptor (EGFR) mutation positive T790M Rekraza® non-small cell lung cancer was approved by the Ministry of Food and Drug Safety ( MFDS) on May 18.
Rekraza is a third generation oral 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, can be use to treat patients with locally advanced or metastatic benign non-small cell lung cancer.
Recraza has received conditional permission for use in patients with advanced non-small cell lung cancer with EGFR-positive mutations who have previously received treatment for lung cancer.
Based on data derived from patients receiving lexaza as second-line therapy in the LASER201 clinical trial (YH25448-201), objective response rate based on independent central review and investigator assessment in the total patient dose group with positive T790M mutation (162 patients) was 59%. And 68%, and the 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 the independent central review and investigator assessment of the T790M-positive patients (76) were 58% and 72%, and 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 be highly commercially successful. This is a scale that ranks fifth in history among new drugs exported by national pharmaceutical companies.
Professor Ahn Myung-joo from Samsung Medical Center’s Department of Hematology and Oncology 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 patients with non-small cell lung cancer 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 national approval of Rekraza has great implications.” “It will be a good treatment alternative for Korean lung cancer patients through clinically significant antitumor effects and safety. It is expected to be the hope of lung cancer patients around the world. ” Professor Byeong-cheol Cho leads Rekraza’s licensed clinical trials and leads the multinational phase 3 clinical trial study.
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