Yuhan Corp.’s epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treatment Leclaza (lazertinib mesylate monohydrate) has won full approval in Korea.

Yuhan said Monday that the company has won approval from the Ministry of Food and Drug Safety (MFDS) for changing Leclaza’s indications by meeting all conditions for the second-line treatment for T790M mutation-positive NSCLC.

As a result, Leclaza has been authorized for the first- and second-line treatment of EGFR mutation-positive NSCLC.

Leclaza received conditional approval from the MFDS for the second-line treatment of EGFR T790M mutation-positive patients on Jan. 18, 2021. On June 30 this year, it was granted marketing authorization in Korea for the first-line treatment of EGFR-positive mutation-positive NSCLC after confirming a statistically significant progression-free survival (PFS) improvement in a multinational phase 3 clinical trial (LASER301 study) for the first-line treatment of EGFR-active mutation-positive NSCLC.

To fulfill the conditions for approval of Leclaza as a second-line treatment, Yuhan integrated data from the cross-over treatment arm of the LASER301 study and cases collected in the post-marketing survey with data from LASER201.

During the period, the company also demonstrated a statistically significant improvement through additional analyses evaluating the efficacy of Leclaza as a second-line treatment compared to an external control group that received platinum-based chemotherapy, applying for a new product approval this past August to convert the conditional approval to full approval.

Kim Yeol-hong, executive vice president for R&D at Yuhan, expressed optimism about the results, saying, "This additional analysis utilized retrospective data from actual clinical sites to evaluate efficacy. We employed a propensity score technique for approval. It is encouraging to observe that the results are based on the objective and scientific judgment of experts regarding the treatment effectiveness of Leclaza in patients with EGFR mutation-positive NSCLC.'"