Handok said Monday that its acute myeloid leukemia (AML) treatment, Vyxeos liposomal injection (ingredients: daunorubicin hydrochloride and cytarabine), was included in Korea’s National Health Insurance coverage as of Sunday.

The coverage applies to adults aged 60 and older who are newly diagnosed with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is reimbursable for both induction and consolidation therapy.

Vyxeos, the first treatment approved for this high-risk patient group, received regulatory approval in Korea in 2022. Licensed from Jazz Pharmaceuticals, headquartered in Ireland, it has already been prescribed in major markets, including the U.S., U.K., France, Germany, Italy, and Switzerland.

Patients with t-AML and AML-MRC typically face poorer outcomes than those with other AML subtypes, with lower remission rates and shorter overall survival (OS) despite intensive chemotherapy. The standard “7+3” regimen—a combination of cytarabine and daunorubicin introduced in the 1970s—has left an unmet need for improved treatments for decades.

Vyxeos delivers daunorubicin and cytarabine in a 1:5 molar ratio within a liposomal formulation, enabling extended retention in bone marrow and selective absorption by leukemia cells. Vyxeos is administered in three four-hour sessions on days 1, 3, and 5, unlike the continuous seven-day infusion required for the 7+3 regimen.

Clinical trials comparing Vyxeos with the 7+3 regimen showed Vyxeos improved outcomes in high-risk AML patients. Median overall survival increased to 9.6 months, compared to 5.9 months with the 7+3 regimen. Vyxeos also achieved higher rates of complete remission (CR) and complete remission with partial hematologic recovery (CRi), at 48 percent (CR 37 percent) compared to 33 percent (CR 26 percent) for the 7+3 regimen. The safety profiles for the two treatments were similar.

Long-term survival data also favored Vyxeos, with a five-year survival rate of 18 percent, compared to 8 percent for the 7+3 regimen. Survival rates at one, two, and five years were 42 percent, 31 percent, and 18 percent, respectively, for Vyxeos, versus 28 percent, 12 percent, and 8 percent for the 7+3 regimen.

Meanwhile, Handok said it is actively expanding its oncology portfolio and enhancing its position in the cancer treatment market. The company exclusively distributes Jazz Pharmaceuticals’ Vyxeos in Korea, along with Pemazyre (pemigatinib) for bile duct cancer and Minjuvi (tafasitamab) for diffuse large B-cell lymphoma.