Yuhan Corporation(73,600 -3.54%)Announced on the 18th that Lecrazazol (ingredient name lasertinib mesylate) has been approved by the Ministry of Food and Drug Safety. Rekraza is a treatment for non-small cell lung cancer that is positive for the epithelial growth factor receptor (EGFR)’T790M’ mutation.
Lung cancer is a carcinoma with the highest mortality rate in Korea. The 5-year survival rate of lung cancer that has metastasized to other organs is only 8.9%. The number of lung cancer patients in 2021 is estimated to be about 30,000. Most of the lung cancers are non-small cell lung cancer, of which 30 to 40% are diagnosed as positive for EGFR mutations. For these patients, 1st and 2nd generation targeted treatments are used, but 50-60% of these patients become resistant by the T790M mutation, so they do not show any effect.
Rekraza, an innovative new drug of Yuhan Corporation, is a third-generation targeted treatment that is resistant to T790M mutation. It is explained that it can pass through the blood-brain barrier (BBB), showing excellent efficacy and tolerability even in lung cancer patients with brain metastases.
Rekraza can be used in patients with T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who are resistant to the first and second generation EGFR targeted treatments. Yuhan Corporation introduced Rekraza in 2015 at the stage just before the preclinical trial and received domestic approval in 2021 through preclinical and clinical trials.
Ahn Myung-ju, a professor of hematology and oncology at Samsung Medical Center, said, “Recraza is the first new drug developed in Korea that has been published in the international journal Lancet Oncology and has been recognized for its efficacy and safety.” It is expected to be a therapy.”
With this permission, Rekraza became the 31st domestically developed new drug. Based on the results of phase 2 clinical trials conducted in Korea, Yuhan applied for permission to perform phase 3 clinical trials after marketing. The Ministry of Food and Drug Safety finally approved the Lecra midnight after consulting the Central Pharmacy Review Committee, which includes experts treating lung cancer in the medical field.
Reporter Minsoo Han [email protected]
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