U.S. FDA approves Yuhan’s novel cancer drug Leclaza

Yuhan Corp.’s non-small cell lung cancer treatment ‘Leclaza’. [Courtesy of Yuhan Corp.]

Yuhan Corp.’s novel cancer drug Leclaza has been approved by the U.S. Food and Drug Administration, becoming the first domestic anticancer drug to advance into the U.S. market.

Yuhan announced on Tuesday that its Leclaza (lazertinib), a non-small cell lung cancer treatment, has received marketing approval from the U.S. FDA, as a combined modality therapy with Johnson & Johnson’s chemotherapy-free treatment Rybrevant (amivantamab).

The approval allows the use of the cancer drug Rybrevant in combination with Leclaza, as a first-line treatment for non-small cell lung cancer patients with a mutated form of a gene called EGFR, those who have either deletions in exon 19 or substitutions of leucine for arginine (L858R) in exon 21 of the EGFR gene.

The combination therapy demonstrated a 30 percent reduction in the risk of disease progression or death compared to Tagrisso monotherapy in a Phase 3 clinical trial called the MARIPOSA study.

The FDA approval also allows Yuhan to obtain an $80 million milestone from Janssen.