Handok’s Minjuvi wins expanded approval for relapsed or refractory follicular lymphoma

Handok said Friday that its cancer drug Minjuvi (tafasitamab) was approved on March 24 by the Ministry of Food and Drug Safety for use in combination with other medicines to treat adults with follicular lymphoma that has come back or did not respond to treatment.

This new use is for adults with follicular lymphoma (grades 1–3a) whose cancer has come back or did not get better after one or more prior treatments.

Minjuvi is an Fc-enhanced humanized monoclonal antibody that targets CD19. It works by inducing direct tumor cell death and enhancing immune responses mediated by natural killer cells and macrophages. CD19, a surface antigen, plays a key role in B-cell proliferation and signaling and is widely expressed in most B-cell malignancies, including follicular lymphoma.

The expansion of Minjuvi’s indications is based on the results of the global phase 3 inMIND clinical trial. The study evaluated the efficacy and safety of adding Minjuvi to lenalidomide and rituximab (R² regimen) in patients with relapsed or refractory follicular lymphoma.

The study results showed that the median progression-free survival (PFS) in the Minjuvi combination group was 22.4 months, representing a 57 percent reduction in the risk of disease progression or death compared with the control group (13.9 months). Additionally, the overall response rate (ORR) was 83.5 percent, and the PET-complete response (PET-CR) rate was 49.4 percent, demonstrating higher treatment responses compared with the control group (72.4 percent and 39.8 percent).

Minjuvi was designated as an orphan drug in Korea in 2021. It received approval in 2023 for the treatment of relapsed or refractory diffuse large B-cell lymphoma. With this latest decision, its indications have been expanded. In 2025, it received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of relapsed or refractory follicular lymphoma.