Yuhan Corporation Applies for Approval to Change Lung Cancer New Drug 'Reclaza' to First-Line Treatment

Yuhan Corporation announced on the 17th that it has applied to the Ministry of Food and Drug Safety for a change approval to add an indication for 'Leclaza' (generic name: Lazertinib Mesylate Monohydrate) as a first-line treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer.

Reclaza.
Photo by Yuhan Corporation

Leclaza was approved by the MFDS on January 18, 2021, as a second-line treatment for EGFR T790M mutation-positive patients. According to the company, a multinational Phase 3 clinical trial conducted last October for first-line treatment of EGFR activating mutation-positive non-small cell lung cancer confirmed a statistically significant improvement in progression-free survival.

Yuhan Corporation previously disclosed detailed clinical trial results at the European Society for Medical Oncology Asia Congress (ESMO Asia) held in Singapore last December.

A Yuhan Corporation official stated, "We have applied for a change approval to expand the domestic indication," adding, "Upon approval, we will be able to provide high-quality pharmaceutical treatment opportunities to more patients as a first-line therapy more quickly."