[대전인터넷신문=종합/박완우 기자] Yuhan Corporation’s non-small cell lung cancer treatment,’Lecrazy’ (lasertinib mesylate), received a new drug license.
The Ministry of Food and Drug Safety announced on the 18th that it has approved Yuhan Corp.’s non-small cell lung cancer treatment’Lecrajajeong (lasertinib mesylate)’ as the 31st new drug developed in Korea.
Yuhan Corporation’s’Lecrazyme’ is used for patients with advanced lung cancer with mutations in a specific gene who have previously been treated for lung cancer, and inhibits the proliferation and growth of lung cancer cells by interfering with signaling involved in lung cancer cell growth. As a target anticancer drug, it is known to have the advantage of being less toxic to normal cells.
Yoohan Corporation’s”Recrajajeong” applied for permission under the condition of conducting a phase 3 clinical trial (therapeutic confirmation clinical trial) after marketing based on the results of a phase 2 clinical trial (therapeutic exploration clinical trial) conducted in Korea. The Ministry has thoroughly reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plan for the applied drug in accordance with the review criteria of the ｢Pharmaceutical Affairs Act｣. The pharmacist review committee gave the final approval after consulting on the completion of the permit and conformity to the system.
The Ministry of Food and Drug Safety expects that the new drug approval will expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer.The safety and effectiveness will be improved by securing objectivity and transparency through scientific and thorough approval and review and expert advice. The plan is to make efforts to supply sufficiently identified treatments.
Reporter Park Wan-woo
- TAG