Yuhan's Lazertinib was approved

The MFDS, conditional marketing authorization for Leclaza, a new drug developed in Korea on the 18th

Used in patients who have experienced EGFR-TKI treatment

The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS.

 

The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States.

 

It is the first country in the world to obtain approval from the FDA.

 

The MFDS announced on the 18th that it has approved Yuhan's non-small cell lung cancer treatment Leclaza (Lazertinib mesylate) as the 31st new drug developed in Korea.

 

Leclaza is used in patients with advanced lung cancer with specific gene mutations who have previously been treated for lung cancer.

 

It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and is less toxic to normal cells.

 

The drug treats patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI.

 

It selectively inhibits the epithelial cell growth factor receptor Tyrosine Kinase, which is involved in the growth, differentiation, and survival of cancer cells, and prevents cancer cell survival, proliferation and metastasis.

 

Yuhan applied to conduct a phase III clinical trial after marketing based on the results of a phase II clinical trial conducted in Korea.

 

The MFDS explained that the quality, safety and effectiveness, and post-marketing safety management plans were scientifically reviewed and evaluated according to the review criteria of the Pharmaceutical Affairs Law.

 

The Central Pharmaceutical Affairs Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the license and conformity to the system.

 

The MFDS said that the approval of the new drug is expected to expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer.

 

It emphasized that it will continue to provide scientific and thorough approvals and reviews, and by securing objectivity and transparency through expert advice, to ensure that the safety and effectiveness of treatments are sufficiently verified.