Yuhan Corp. said it will seek approval from the U.S. Food and Drug Administration (FDA) for its lung cancer treatment, Leclaza, as first-line therapy for non-small cell lung cancer (NSCLC) in earnest from next year.

Yuhan Corp. said it will seek approval from the U.S. Food and Drug Administration (FDA) for its lung cancer treatment, Leclaza, as a first-line therapy from next year at a press conference in Seoul on Tuesday.
Yuhan Corp. said it will seek approval from the U.S. Food and Drug Administration (FDA) for its lung cancer treatment, Leclaza, as a first-line therapy from next year at a press conference in Seoul on Tuesday.

Leclaza (YH25448) is an oral, highly potent, mutant-selective, and irreversible EGFR tyrosine-kinase inhibitor (TKI) that targets both the T790M mutation and active EGFR mutations as a third-generation non-small cell lung cancer (NSCLC) treatment.

At the recently concluded ESCMO Asia conference, Yuhan announced that Leclaza recorded 20.6 months of progression-free survival period (PFS) compared to AstraZeneca's NSCLC treatment, Iressa (gefitinib), which recorded 9.7 months in phase 3 clinical trials.

The PFS period is an important evaluation index that can confirm the efficacy of anticancer drugs and refers to the period in which the disease does not progress or die, such as the size of the tumor growing.

"Leclaza's global phase 3 clinical trial is in the spotlight now and shows potential for first-line therapy," said Yunhan Corp. CEO Cho Wook-je at a press conference in Seoul, Tuesday. "We have decided to apply for a change of permission to expand its indication as a first-line therapy and will seek FDA approval together with Janssen next year."

Leclaza won approval from the Ministry of Food and Drug Safety last year as second-line therapy for NSCLC which is given to a patient when initial treatment is not effective.

However, Yuhan plans to first seek the MFDS' approval as first-line therapy in the first quarter of next year. Once the change in indication is granted, the company will subsequently go through the process of applying for health insurance benefits and negotiating drug prices.

"From a licensing point of view, I don't think there will be a problem as we have met the primary evaluation indicators and Leclaza shows advantages over competing drugs," said Yuhan executive director Lim Hyo-young.

Regarding the drug price negotiations, Lim added, “Since innovative new drugs developed by domestic pharmaceutical companies will be the first drug prices to indicate our global strategy, we will negotiate carefully and balance this with patient convenience.”

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