midostaurin
midostaurin: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.
midostaurin evidence translation
What we can confirm
1 FDA record · 2 tracked trials
What it means
What to watch
Prepared research question
How could midostaurin → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (3)
| Company | Phase |
|---|---|
| Novartis AG (NVS) FLT3-mutated Acute Myeloid Leukemia | Phase 2 |
| Novartis AG (NVS) | Approved |
| Novartis AG (NVS) | Approved |
Clinical Trials (2)
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 Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML
Primary endpoint: Part 1 of the study: Occurence of dose limiting toxicities (DLT)
FDA Decisions1 records
Frequently asked questions
Who is developing midostaurin?
midostaurin is being developed by Novartis AG.
How many clinical trials involve midostaurin?
BioSniper tracks 2 clinical trials involving midostaurin.
What is midostaurin's latest FDA decision?
The most recent tracked FDA decision for midostaurin is Approval, dated April 28, 2017.