Global Expansion of Yuhan Corporation's 'Leclaza' Terminology Explanation... What Does 'EGFR Mutation' Mean? [AK Radio]

A historic moment has arrived in the domestic pharmaceutical industry. Yuhan Corporation's lung cancer treatment drug, "Reclaza," has received approval from the U.S. Food and Drug Administration (FDA). This marks the first FDA approval for a new drug independently developed by a Korean pharmaceutical company, serving as an important milestone that demonstrates the global competitiveness of Korea's pharmaceutical industry.

Reclaza is an "epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer treatment." To understand this complex term, several key concepts must be known. EGFR is a term combining four concepts: "epidermis," "growth factor," "receptor," and "mutation." Epidermal cells refer to the cells forming the outermost layer of our body's organs, growth factors are signals that direct the growth and differentiation of these cells, receptors are proteins that transmit these signals inside the cells, and mutation means that this receptor has undergone a genetic alteration causing the signal to remain continuously active.

Non-small cell lung cancer accounts for 80-85% of all lung cancers. It refers to lung cancer with relatively larger cancer cells and is distinguished from small cell lung cancer. Reclaza is used only in cases of non-small cell lung cancer with EGFR mutations. This mutation occurs in about 20-30% of Western patients and approximately 40% of Asians, including Koreans.

A notable point in this FDA approval is that Reclaza was approved as a first-line therapy. First-line therapy means the treatment approved for initial use in patients. Compared to second-line therapy (used when the first drug is ineffective), first-line therapy has a broader application scope and is expected to significantly contribute to increased sales.

The effectiveness of Reclaza is evaluated by the "median progression-free survival (PFS)." PFS refers to the period during which cancer cells do not grow after drug administration, and the median indicates the PFS of the patient positioned in the middle among all patients. The combination therapy of Reclaza and AstraZeneca's anticancer drug Livtencity showed a median PFS of 23.7 months, which is 7 months longer than the 16.6 months of the existing treatment Tagrisso. This means that the Reclaza combination therapy can delay cancer progression for a longer period.

The FDA's new drug approval standards are strict. Fundamentally, a new drug must demonstrate at least equivalent or superior efficacy compared to existing drugs. The Reclaza-Livtencity combination therapy was able to gain approval because it proved superior efficacy in several aspects over Tagrisso, the current leader in the lung cancer treatment market, through global clinical trials.

This approval is significant not only as the success of a single product but also as a new milestone for the domestic pharmaceutical industry. The success of Reclaza will inspire the research and development ambitions of Korean pharmaceutical companies and serve as an example showing the potential for global market entry.

However, complacency with these achievements is not warranted. Competition in the global pharmaceutical market will become even fiercer, requiring continuous research, development, and innovation. Additionally, responsible attitudes from the pharmaceutical industry are demanded regarding various social issues such as ethical concerns in new drug development, appropriate drug pricing, and medical accessibility.

The FDA approval of Reclaza has opened a new chapter for Korea's pharmaceutical industry. It is hoped that this will enable the Korean pharmaceutical industry to stand out more prominently in the global market and ultimately contribute to improving human health and quality of life. Continued attention will be necessary regarding Reclaza's actual market performance, additional clinical results, and the potential expansion of its application scope.