Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMF-500 · 1 trial · 1 indication
Assessed by the NCI CTCAE version 5.0.
Assessed by the NCI CTCAE version 5.0.
Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.
| Arm | Type | Description |
|---|---|---|
| Arm A: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity. |
| Arm B: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors. |
| Arm C: Escalation Phase | EXPERIMENTAL | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors. |
| Name | Type | Description |
|---|---|---|
| BMF-500 | DRUG | Investigational Product |
Key Inclusion Criteria: * Age ≥ 18 years. * Individuals with histologically or pathologically confirmed diagnosis of AML with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (including those with MLL1-R a...
BMF-500 is an investigational small molecule being developed for the treatment of acute myeloid leukemia, a cancer of the blood and bone marrow. It is being studied in adults with acute leukemia, including biomarker-selected patients. BMF-500 has not been approved by the FDA and remains in clinical development.
BMF-500 targets FLT3, a gene that encodes a receptor tyrosine kinase involved in acute myeloid leukemia. FLT3 alterations are among the most common mutations in AML. BMF-500 is a small molecule designed to act against this target, and the Phase 1 study enrolled biomarker-selected patients.
BMF-500 is being developed by Biomea Fusion, Inc., which trades on the Nasdaq under the ticker BMEA. The company is the sponsor of the clinical program evaluating BMF-500 in acute leukemia, including the completed Phase 1 study conducted in the United States.
BMF-500 is in Phase 1 clinical development. Its single registered trial, a Phase 1 study in adults with acute leukemia, has completed. BMF-500 is investigational and has not been approved by the FDA for any indication.
BMF-500 has been evaluated in one registered clinical trial, NCT05918692, titled A Phase 1 Study of BMF-500 in Adults With Acute Leukemia. The trial enrolled 35 participants, was controlled, was not randomized or double blinded, and has completed. It was conducted in the United States in patients aged 18 years and older.