Has Revumenib-Revuforj been launched in the country?

Revuforj (Revumenib)-Revuforj is an oral targeted drug that is currently attracting international attention. It was granted accelerated approval by the US FDA for the treatment of patients with acute leukemia (including acute myeloid leukemia AML and acute lymphoblastic leukemia ALL) associated with KMT2A gene rearrangement. The clinical characteristics of this type of leukemia are rapid disease progression, poor prognosis, and limited efficacy of traditional treatments. Therefore, the advent of Revuforj is regarded as an important milestone in the field of precision medicine in the field of hematological tumors. Its pharmacological mechanism is to interfere with the core molecular drive of leukemia by blocking the interaction between menin and KMT2A fusion protein, thereby inhibiting the proliferation of malignant cells.

However, in the domestic market, as of now (2025.9.30), Revuforj-Revuforj has not yet been officially launched. There is no public information in China showing that the drug has been approved by the national drug regulatory authority, which means that patients currently cannot obtain the drug through conventional medical channels. Some patients may be exposed to the drug through international drug introduction channels or clinical trial opportunities, but this is not equivalent to being marketed domestically. Considering the high-demand field of leukemia, whether the drug will be introduced into the country in the future depends on the progress of the manufacturer's registration application and the review results of the clinical data by the national drug regulatory department.

For domestic patients, the current treatment of leukemia mainly relies on chemotherapy, hematopoietic stem cell transplantation and other approved targeted drugs, and the launch of Revimenib is expected to bring new options to patients with KMT2A rearrangements. It is worth noting that with the acceleration of global approval of innovative drugs, Revuforj is more likely to enter the Chinese market in the future, but it still needs to wait patiently for its official approval. If patients need to know more relevant information, they can follow the updates of the Drug Evaluation Center of the State Food and Drug Administration, or consult a professional hematologist for compliance channels.

Reference materials:https://www.drugs.com/monograph/revumenib.html