Boryeong, Small Cell Lung Cancer New Drug 'Zepzelca' Receives MFDS Approval

Expanded Second-Line Treatment Options for Small Cell Lung Cancer
Planned Release in the First Half of Next Year

Jebjelka CI.

[Asia Economy Reporter Lee Gwan-joo] Boryung (formerly Boryung Pharmaceutical) announced on the 26th that it has obtained marketing approval from the Ministry of Food and Drug Safety for the small cell lung cancer drug "Zepzelca (generic name: lurbinectedin)."

Zepzelca is indicated for "metastatic small cell lung cancer that has failed first-line platinum-based chemotherapy" and received domestic approval from the Ministry of Food and Drug Safety on the 22nd. This approval comes two years after it was designated as an orphan drug in July 2020.

Zepzelca is an anticancer drug developed by the Spanish pharmaceutical company PharmaMar S.A., and Boryung has held exclusive rights for domestic development and sales since 2017.

In the United States, it was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2018, received conditional accelerated approval and priority review in June 2020, and was launched in July of the same year. In Korea, it is planned to be launched in the first half of next year through this marketing approval.

Small cell lung cancer generally metastasizes early and progresses faster compared to non-small cell lung cancer. It is also known to have a high recurrence rate after treatment. Platinum-based therapy is the representative treatment for small cell lung cancer, and Zepzelca is expected to become a new treatment option for patients who show resistance or relapse.

Zepzelca is administered only for one hour on day 1 every 21 days, making it easier to administer compared to other treatment options. Due to these characteristics, it has captured about 40% of the second-line treatment market for small cell lung cancer patients who failed first-line platinum-based therapy within two years of its launch in the U.S.

Kim Young-seok, head of Boryung's Onco division, said, "Until now, treatment options for small cell lung cancer patients who failed platinum-based chemotherapy have been quite limited," adding, "Zepzelca will be a new choice that significantly improves treatment outcomes for small cell lung cancer."

This content was produced with the assistance of AI translation services.