[Asia Economy Reporter Cho Hyun-ui] Yuhan Corporation's non-small cell lung cancer treatment 'Reclaza Tablets (active ingredient: Lazertinib)' has been approved as the 31st domestic new drug in Korea.
On the 18th, the Ministry of Food and Drug Safety announced that Reclaza Tablets, a targeted anticancer drug that inhibits signal transduction involved in lung cancer cell growth to suppress the proliferation and growth of lung cancer cells, have been approved as a new drug.
Reclaza Tablets are used for patients with advanced lung cancer who have specific gene mutations and have previously undergone lung cancer treatment. It selectively inhibits the epithelial growth factor receptor tyrosine kinase involved in the growth, differentiation, and survival of lung cancer cells, thereby preventing cancer cell survival, proliferation, and metastasis, while exhibiting low toxicity to normal cells.
Yuhan Corporation applied for approval on the condition of conducting a Phase 3 clinical trial after marketing, based on the results of a Phase 2 clinical trial conducted domestically.
The Ministry of Food and Drug Safety scientifically and thoroughly reviewed and evaluated the quality, safety and efficacy, and post-marketing safety management plans according to the Pharmaceutical Affairs Act's review standards. The final approval was granted after consultation with the Central Pharmaceutical Review Committee, which includes experts treating lung cancer in medical fields, regarding the completeness of Reclaza's approval and compliance with regulations.
Lee Jung-hee, CEO of Yuhan Corporation, said, "Reclaza is a domestic new drug that has received great interest and positive medical evaluations since its development stage," adding, "With this approval, we can provide a new treatment option for patients with EGFR mutation-positive non-small cell lung cancer in Korea."
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