Is melphalan/melphalan for injection on the market?

Melphalan for injection/Melphalan flufenamide is a drug used to treat multiple myeloma and has received widespread attention in recent years. It was developed primarily to improve the efficacy and safety of traditional melphalan. Melphalan is a classic chemotherapy drug, but its use is often accompanied by major side effects, such as bone marrow suppression, nausea, etc. Therefore, researchers hope to reduce side effects by improving the chemical structure while maintaining or enhancing anti-tumor activity.

Clinical trial results show that it is highly effective in patients with multiple myeloma, especially those who are resistant to traditional treatments. In addition, the drug also demonstrated a relatively good safety profile in terms of tolerability, making it a promising treatment option.

Regarding the marketing status of the drug, according to relevant information, melphalan for injection was approved for medical use in the United States in February 2021 and in the European Union in August 2022, especially in patients with relapsed or refractory multiple myeloma who have experienced at least one systemic therapy. This provides new treatment options for many drug-resistant patients. In October 2021, Melphalan for injection was withdrawn from the U.S. market after data from the OCEAN trial showed no improvement in overall survival compared with pomalidomide.

Melphalan for injection has been approved and sold on the market in some countries and regions. The benefits of melphalan for injection outweigh its risks. Patients with multiple myeloma have unmet medical needs and their condition can no longer be improved with existing treatments. Although there are some limitations to these studies, the results are considered clinically relevant, except in the subgroup of patients who received autologous stem cell transplants and whose disease progressed within three years of transplantation. Regarding safety, although side effects, including serious side effects, were observed during treatment with injectable melphalan, these side effects were considered acceptable and manageable.