Posted by Michael Wonder on 19 Jan 2021
Regulators OK Yuhan's Leclaza as 31st novel drug
18 January 2020 - Yuhan said Monday that it has received sales approval for Leclaza (lazertinib), a drug targeting epidermal growth factor receptor T790M mutated non-small-cell lung carcinoma, from the Ministry of Food and Drug Safety.
The Ministry based its approval on the results of the Phase 2 clinical trial conducted in Korea.
Yuhan had applied for permission under the condition of conducting a Phase 3 clinical trial after marketing.
