Represented Yuhan Corporation in Obtaining Approval and Reimbursement for Leclaza
2023.06.30.
Yulchon successfully secured modified approval from the Ministry of Food and Drug Safety (MFDS) for the use of Yuhan’s Leclaza as a first-line treatment for lung cancer. Leclaza, the 31st domestically developed drug in Korea, is a targeted anticancer agent for patients with an epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. Prior to this amended approval, Leclaza was exclusively administered as a second-line treatment to patients unresponsive to other therapeutic options.
Yulchon assisted Yuhan in ensuring that Leclaza became eligible for reimbursement when it was first approved as a second-line treatment in 2021. Notably, it took only 164 days for Leclaza to enter the health insurance market following its approval, a duration significantly shorter than the domestic average of approximately 1,000 days for anticancer drugs.
The recent modification of approval by the MFDS allows Leclaza to be used as a first-line treatment immediately after a lung cancer diagnosis, without the necessity of trying other treatments first. This marks the first instance of a domestically produced lung cancer drug receiving approval as a first-line treatment. Additionally, Yulchon has initiated efforts to ensure reimbursement for Leclaza's use as a first-line treatment.
Leclaza, classified alongside AstraZeneca's Tagrisso as a third-generation targeted anticancer agent for lung cancer, is anticipated to compete with Tagrisso in the global market. Thus, the successful market entry of Leclaza holds significance, marking a notable achievement for Yulchon's Healthcare Team.
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