asciminib
asciminib: developed by 1 company · 12 clinical trials tracked · 1 FDA decision.
asciminib evidence translation
What we can confirm
1 FDA record · 12 tracked trials
What it means
What to watch
Prepared research question
How could asciminib → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| Novartis AG (NVS) | Approved |
Clinical Trials (12)showing 10 most recent
Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Primary endpoint: Recommended Phase 2 Dose
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Primary endpoint: Major molecular response (MMR) rate by 12 months
A Prospective, Multicenter, Single-arm, Open-label, Phase IV, Post-authorization Interventional Study to Assess the Safety and Efficacy of Asciminib in Indian Patients With Ph+ CML-CP (Without T315I Mutation), Previously Treated With Two or More Tyrosine Kinase Inhibitors and Ph+ CML-CP With T315I Mutation
Primary endpoint: Frequency and severity of adverse events(AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP without T315I mutation
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Primary endpoint: Safety and adverse events (AEs)
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Primary endpoint: Safety and adverse events (AEs)
A Phase 3, Multicenter, Randomized, Open-Label, Trial Evaluating the Efficacy and Safety of Asciminib Used in Consolidation With Imatinib v. Imatinib to Achieve Treatment-free Remission in Chronic Phase-Chronic Myelogenous Leukemia Patients
Primary endpoint: Event-free survival rate
A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.
Primary endpoint: Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Primary endpoint: One-year "second" treatment-free remission.
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Primary endpoint: Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI
Frontline Asciminib Combination in Chronic Phase CML
Primary endpoint: deep molecular response (Rate of MR4)
FDA Decisions1 records
Frequently asked questions
Who is developing asciminib?
asciminib is being developed by Novartis AG.
How many clinical trials involve asciminib?
BioSniper tracks 12 clinical trials involving asciminib.
What is asciminib's latest FDA decision?
The most recent tracked FDA decision for asciminib is Approval, dated October 29, 2021.