Revumenib Meets CR/CRh End Point in NPM1+ R/R AML
2 days ago · Revumenib achieved a 23% complete remission rate in NPM1-mutated AML patients, meeting the primary endpoint of the AUGMENT-101 trial. The overall response rate was 47%, with 17% of responders ...
Revumenib Shows Promise for Advanced Acute Myeloid Leukemia
Apr 18, 2023 · A new type of targeted therapy shows promise for acute myeloid leukemia (AML), one of the most difficult leukemias to treat. The drug, revumenib, is part of a group, or class, of drugs known as menin inhibitors. In an early-phase clinical trial called AUGMENT-101, treatment with revumenib caused about one-third of study participants’ cancers ...
Syndax Announces Positive Pivotal Topline Results from Relapsed …
3 days ago · Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia - July 29, 2024; Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia - March 26, 2024; Revumenib FDA Approval History. More news resources. FDA Medwatch …
Revumenib for NPM1-Mutant AML Succeeds in Pivotal Trial
2 days ago · Revumenib is an oral, small molecule inhibitor that targets the menin-KMT2A binding interaction and is being developed to treat KMT2A -rearranged (KMT2Ar), or mixed lineage leukemia rearranged (MLLr), acute leukemias, including acute lymphoid leukemia (ALL) and AML, as well as m NPM1 AML. The phase 2 AUGMENT-101 trial previously demonstrated ...
Syndax Announces Positive Data for Revumenib in Patients with …
Dec 11, 2023 · The new combination data collectively highlight revumenib's potential to safely combine with current standard of care agents across the acute leukemia treatment landscape, and support expansion...
Syndax's Revumenib Trial Reports Positive Data In …
2 days ago · Looking ahead, Syndax expects to receive FDA approval for Revumenib for the treatment of relapsed or refractory KMT2Ar acute leukemias in the fourth quarter of 2024.
Syndax Announces U.S. FDA Breakthrough Therapy Designation …
Dec 5, 2022 · Revumenib was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Commission for the treatment of patients with AML, and Fast Track designation by the FDA...
Revumenib Found Effective Against High-Risk KMT2Ar Acute …
Dec 12, 2023 · Based on these results, researchers say revumenib provides a promising avenue to allow more patients to proceed to a stem cell transplant, the only known curative treatment for aggressive and hard-to-treat KMT2Ar cancers.
Acute leukemia: Menin-targeting drug revumenib ... - Medical News Today
Mar 21, 2023 · In a new clinical trial, of the 60 people with certain types of acute leukemia who took a new drug called revumenib, 30% experienced complete remission of the disease. Researchers are now hoping...
Revumenib represents a ‘significant breakthrough’ for ... - Healio
Dec 12, 2023 · Revumenib proved safe and effective among pediatric and adult patients with relapsed or refractory KMT2Ar acute myeloid leukemia and acute lymphoid leukemia, according to study results presented...