Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asciminib single agent · 1 trial · 2 indications
MMR is defined as BCR::ABL1 IS ≤0.1%. MMR is defined as a ≥ 3.0 log reduction in BCR::ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1 % BCR::ABL1/ABL % by international scale as measured by RQ-PCR.
| Arm | Type | Description |
|---|---|---|
| Single arm study | EXPERIMENTAL | This study will enroll pediatric patients (≥ 1 and \< 18 years of age) with newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation |
| Name | Type | Description |
|---|---|---|
| Asciminib single agent | DRUG | Asciminib (labelled as ABL001) administered as 40 mg tablet (adult formulation) or as 1 mg film-coated granules mini-tablets (pediatric formulation) |
Key Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female participants 1 and \< 18 years of age at study enrollment 3. Diagnosis of CML-CP (Ap...
Asciminib single agent is used for chronic myelogenous leukemia (CML), specifically in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). It is an investigational small molecule being studied as a single agent for this indication.
Asciminib single agent is a kinase inhibitor, belonging to the -nib class of targeted cancer therapies. It works by inhibiting kinase activity, which plays a role in the growth and survival of cancer cells in chronic myelogenous leukemia.
Asciminib single agent is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety in pediatric patients with Ph+ CML-CP.
Asciminib single agent is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness.
Asciminib single agent is being studied in one active Phase 2 clinical trial with the identifier NCT07354074. This trial is recruiting participants to evaluate the efficacy and safety of asciminib in pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase.
Asciminib single agent refers to the drug asciminib when used as a monotherapy, meaning it is administered alone rather than in combination with other treatments. In the context of the clinical trial, it is being studied as a single agent for pediatric patients with Ph+ CML-CP.