MFDS Approves Imported Rare Disease Drug for Non-Small Cell Lung Cancer and Solid Tumors

Expanding Treatment Options with "Oktairo Capsule"

The Ministry of Food and Drug Safety announced on June 5 that it has approved the rare disease drug "Oktairo Capsule (ingredient: repotrectinib)," which is imported by Korea BMS Pharmaceutical.

This medication is used to treat adult patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer. It is also indicated for the treatment of locally advanced, metastatic, or surgically unresectable solid tumors with a high risk of severe morbidity in adults and pediatric patients aged 12 years and older who have NTRK gene fusions.

When mutations occur in the ROS1 and NTRK genes, abnormal proteins are continuously expressed, activating downstream cellular signaling pathways involved in cell proliferation and survival, which in turn induces the proliferation of cancer cells.

Repotrectinib exerts its anticancer effect by inhibiting proteins such as ROS1 that are involved in cancer cell proliferation, thereby suppressing the growth and survival of cancer cells and inducing cancer cell death.

The Ministry of Food and Drug Safety expressed its expectation that "Oktairo Capsule will provide a new treatment opportunity for patients with ROS1-positive non-small cell lung cancer or solid tumors with NTRK gene fusions."

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