Yuhan Corporation’s “Leclaza (Ingredient: Lazertinib)”, a third-generation targeted therapy for EGFR T790M-mutated NSCLC, has received approval as a 2nd line of therapy from the South Korean Ministry of Food and Drug Safety as Korea’s 31st novel drug. 

Leclaza will be administered to the patients who have previously been treated for lung cancer but now have recurrent advanced lung cancer with mutations in specific genes. As a targeted anticancer treatment, Leclaza inhibits the growth and proliferation of lung cancer cells by interfering with the signal transmission. It has the advantage of being less toxic to normal cells. It has also shown excellent efficacy and tolerability to lung cancer patients with brain metastases as it can pass through the blood-brain barrier (BBB).

The Ministry of Food and Drug Safety announced that their approval was based on the results of the phase 2 clinical trial conducted in Korea, and it was granted on the condition that Yuhan conducts Phase 3 clinical trials after the sales begin. 

The Ministry also explained that the quality, safety, effectiveness, and post-marketing safety management plans for the applied drug were thoroughly reviewed and evaluated in accordance with the criteria of the Pharmaceutical Affairs Act.

The health authority said, “Through this new drug approval, we expect to expand the range of drug options for the treatment for NSCLC patients with positive EGFR T890 mutations.”

Yuhan retains the commercialization rights to Leclaza in South Korea, while Janssen has the global commercial rights outside of South Korea. 

No alt text provided for this image