SEOUL– Yuhan Corp., a South Korean pharmaceutical firm, on Tuesday expressed its intention to push for approval from the U.S. Food and Drug Administration (FDA) for its lung cancer treatment, Leclaza, as first-line therapy next year with its overseas partner Janssen.

Leclaza (lazertinib) is a third-generation non-small cell lung cancer (NSCLC) treatment used for patients who have advanced epidermal growth factor receptor mutations.

Yuhan said Leclaza recorded 20.6 months of progression-free survival period (PFS) in its multinational phase 3 clinical trials, meaning a patient shows no symptoms of worsening over the period.

It is longer than AstraZeneca’s NSCLC treatment, Iressa (gefitinib), which posted 9.7 months of PFS. Iressa won FDA approval for first-line treatment in 2015.

“The result of Leclaza’s global phase 3 clinical trial won favorable reviews and shows potential for first-line therapy,” said Cho Wook-je, CEO of Yuhan Corp., in a press conference held in Seoul. “We will apply for a change of permission to expand its indication to first-line therapy and seek approval from the U.S. Food and Drug Administration in cooperation with Janssen next year.”

First-line therapy refers to a treatment that is accepted as best for the initial treatment of a condition or disease.

Leclaza won approval from the Korean drug authorities last year as second-line therapy, given to a patient when initial treatment doesn’t work or stops working.

Yuhan said Cho expressed the company’s longterm plan to help Leclaza go overseas.

Yuhan needs Janssen Pharmaceuticals’ consent to win approval from the U.S. FDA as Janssen holds global sales rights of Leclaza.

Source: Yonhap News Agency