Revuforj: New Hope For Patients With Acute Leukaemia
On 15 November 2024, the US Food and Drug Administration (FDA) approved a new drug called Revuforj (revumenib) for the treatment of adult and paediatric patients aged 1 year and older with relapsed or refractory (R/R) acute leukaemia who carry a lysine methyltransferase 2A gene (KMT2A) translocation.
This approval marks Revuforj as the first and only menin inhibitor approved for the treatment of these patients, providing a new therapeutic avenue for those for whom conventional therapies have failed.
Revuforj’s Mechanism Of Action
Revuforj is an oral, selective inhibitor of the menin KMT2A interaction, which works by blocking the interaction between menin and the mixed spectrum leukaemia protein (MLL).
It inhibits the activation of specific genes that promote leukaemia cell development, thereby targeting certain types of leukaemia cells and inhibiting their survival, growth and production.
Key Data: Durable Remission And Survival Benefit
Approval was based on results from the AUGMENT-101 phase III clinical trial (NCT04065399):
Composite complete remission rate (CRc): up to 32% (43/134) in the KMT2A-r cohort and 28% (37/132) in the NPM1-m cohort
Median duration of remission (mDOR): 6.7 months (some patients sustained remission >12 months)
Survival benefit: 3.1 months longer median overall survival (mOS) compared to controls (7.5 vs 4.4 months)
Notably, 25% of patients in remission subsequently underwent successful stem cell transplantation, creating an opportunity for long-term cure.
Revolutionary Mechanism: Hitting The Leukaemia ‘Gene Switch’ Directly
Revumenib, as the first menin-KMT2A small molecule inhibitor, inhibits the key signalling pathway leading to leukaemia by precisely blocking the binding of menin protein to the KMT2A (formerly MLL) fusion protein.
Preclinical studies have shown that the drug significantly inhibits malignant cell proliferation and induces differentiation.
Market Outlook
Syndax expects that 25 mg tablets will be available for the treatment of patients weighing less than 40 kilograms by the end of the first quarter or the beginning of the second quarter of 2025.
Prior to the launch of the 25 mg tablets, revumenib oral solution will be marketed through the Expanded Access Programme for patients weighing less than 40 kg.
Future Outlook
The approval of Revuforj provides a new therapeutic option for patients with acute leukaemia, and its significant efficacy and relatively good safety profile make it a promising prospect in the market.
In the future, with the in-depth study of menin protein and KMT2A gene rearrangement, and more clinical trials, the scope of indications of Revuforj may be further expanded.
Meanwhile, the combination with other drugs may also bring better therapeutic effects and survival benefits for patients with acute leukaemia.
However, DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.
We welcome you to reach out to us to buy revumenib. DengYueMedicine is here to provide detailed medicine information, pricing, and support to ensure a smooth and reliable buying experience.
Feel free to contact us anytime to discuss your needs or ask any questions about the medicine.
Information from DengYueMed, China Drug Import and Export Wholesaler offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.
