revumenib
revumenib: sourced relationships with 1 company · 18 clinical trials tracked · 1 FDA decision.
revumenib evidence translation
What we can confirm
1 FDA record · 18 tracked trials
What it means
What to watch
Prepared research question
How could revumenib → SNDX affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Syndax Pharmaceuticals Inc (SNDX) Colorectal Cancer; Acute Myeloid Leukemia; Acute Myeloid Leu… | Phase 3 |
Clinical Trial Registry Records (18)showing 10 most recent
Expanded Access Program for SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemias With Genetic Alterations Associated With HOXA Overexpression
Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis
Primary endpoint: Dose limiting toxicity (DLT)
Phase 2 Randomized Controlled Study of Revumenib as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With KMT2Ar, NPM1m, or NUP98r Acute Myeloid Leukemia (AML)
Primary endpoint: Relapse free survival (RFS) in KMT2Ar, NPM1m, and NUP98r AML in the Intent-to-Treat (ITT) population with a minimum of 1 year of follow-up post-randomization.
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
Primary endpoint: Safety and adverse events (AEs).
A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)
Primary endpoint: Dose limiting toxicities (Safety run-in: Cohort A)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
Primary endpoint: Event Free Survival
Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy
Primary endpoint: Overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.
A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML
Primary endpoint: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
Primary endpoint: Safety and adverse events (AEs)
A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged Disease.
Primary endpoint: Maximum tolerated dose (MTD) for Induction
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with revumenib?
revumenib has dated SEC/FDA relationship records for Syndax Pharmaceuticals Inc.
How many clinical trials involve revumenib?
BioSniper tracks 18 clinical trials involving revumenib.
What is revumenib's latest FDA decision?
The most recent tracked FDA decision for revumenib is Approval for 1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. REVUFORJ is indicated for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , and Clinical Studies (14.1) ] in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options., dated November 15, 2024.