Scemblix   (Asciminib) 
           CML        Chronic Myeloid Leukemia
​

"SCEMBLIX® (asciminib) tablets is a prescription medicine used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitor (TKI) medicines. The effectiveness of SCEMBLIX in these patients is based on a study that measured major molecular response (MMR) rates. No clinical information is available to show if these patients treated with SCEMBLIX live longer or if their symptoms improve. Ongoing studies exist to find out how SCEMBLIX works over a longer period of time.
SCEMBLIX is also approved for use in adults with Ph+ CML in CP with the T315I mutation."
Extract of  FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia, October 29, 2021, Novartis

CLINICAL TRIALS

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
July 6, 2018, ClinicalTrials.gov

A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors
May 25, 2018, ClinicalTrial.gov

A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL
May 4, 2018, ClinicalTrial.gov

CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL
March 29, 2018, CML Advocates Network

A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) – Australian Cancer Trial  
2018, MDAnderson Cancer Center

Phase I Study of oral ABL001 in patients with CML or Ph+ALL 
February7, 2018, European Leukemia Trial Registry

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
April 10, 2017, ClinicalTrial.gov
​
                                All clinical trials with asciminib 
ARTICLES

Novartis Scemblix®, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukemia
August 29, 2022, Novartis
 
European Commission Approves Asciminib in Philadelphia Chromosome–Positive CML
August 29, 2022, Cancer Network
​
Asciminib Improves Efficacy vs Other Third-Line Treatments in Chronic Phase CML
July 22, 2022, Targeted Oncology

Novartis receives positive CHMP opinion for Scemblix®, a novel treatment for adult patients with chronic myeloid leukemia
June 24, 2022, Novartis

Expert Commentary on the Product Profile of Asciminib
April 8, 2022, CancerNetwork

Asciminib Shows Superior Efficacy to Bosutinib for Patients With CML in Chronic Phase
January 20, 2022, Hematology Advisor

Comparing Asciminib With Bosutinib in Patients With Chronic-Phase Chronic Myeloid Leukemia
December 17, 2021, DocWireNews

Patients With Chronic-Phase CML Achieved Deeper, More Durable Molecular Responses With Asciminib Vs Bosutinib
December 13, 2021,  CancerNetwork

Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemia      
December 11, 2021, GlobeNewswire

FDA Approves Scemblix for Pretreated CML in the Chronic Phase
October 29, 2021,  Cure Today

FDA approves Novartis Scemblix® (asciminib), with novel mechanism of action for the treatment of chronic myeloid leukemia
October 29, 2021, Novartis

FDA Accelerates Review of Asciminib for Patients with Chronic Myeloid Leukemia
August 27, 2021, Pharmacy Times

FDA Grants Priority Review to Asciminib for Chronic Myeloid Leukemia
August 25, 2021, OncLive

A Phase 3, Open-Label, Randomized Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After ≥2 Prior TKIs
August 18, 2021,  ASH  Publications -  Blood

Asciminib for the Treatment of Patients With Chronic Myeloid Leukemia
April 2021, Clinical Advances in Hematology and Oncology

Asciminib in chronic myeloid leukemia: many questions still remain to be answered
April 29, 2021, Blood Journal Cancer

FDA Grants Breakthrough Therapy Designation to Asciminib for 2 CML Indications
February 10,2021, Cancer Network

FDA Grants Breakthrough Therapy Designations to Asciminib for CML
February 9, 2021, OncLive
 
FDA Grants 2 Breakthrough Therapy Designations to Asciminib in Ph+ CML
February 8, 2021, Targeted Therapy

Novartis eyes 2021 regulatory submissions for ‘STAMP’ inhibitor asciminib
December 9, 2020, PMLive

Asciminib Represents New Safe and Effective Treatment Option for Heavily Pretreated CML
December 6, 2020,  Targeted Oncology

The specificity of asciminib, a potential treatment for chronic myeloid leukemia, as a myristate-pocket binding ABL inhibitor and analysis of its interactions with mutant forms of BCR-ABL1 kinase
November 2020, Leukemia Research
 
Novartis Push To Expand Cancer Arsenal Gets Trial Win Against Pfizer Bosulif
August 28, 2020, Medical Dialogues

Novartis reports positive data of asciminib in ASCEMBL trial
August 27, 2020, Clinical Trials Arena

Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study
August 26, 2020, PipelineReview.com

Novel ABL1 Kinase Inhibitor Active in Heavily Pretreated CML
January 27, 2020, Oncology Learning Network
​
Asciminib Shows Clinical Activity for Pretreated CML in Phase 1 Trial
January 13, 2020, Cancer Therapy Advisor

​Asciminib Active in Patients With Heavily Pretreated CML
January 6, 2020, Oncology Learning Network
​
Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure
December 12, 2019, The New England Journal of Medicine
​
Step forward in leukemia treatment
December 12, 2019, South Australian Health and Medical Research Institute
​
Leukaemia breakthrough as scientists find drug can fight the blood cancer without causing toxic side effects seen in currently-used medications
December 11, 2019, Daily Mail Health
​
Combining the Allosteric Inhibitor Asciminib with Ponatinib Suppresses Emergence of and Restores Efficacy against Highly Resistant BCR-ABL1 Mutants
September 4, 2019, PubMed
​
Asciminib, a Specific Allosteric BCR-ABL1 Inhibitor, in Patients with Chronic Myeloid Leukemia Carrying the T315I Mutation in a Phase 1 Trial
December 3, 2018,  ASH2018

Mechanisms of resistance to the BCR-ABL1 allosteric inhibitor asciminib.
August 18, 2017, Europe PMC

Double trouble for CML - ABL001 and TKIs
April 5, 2017, Science Translational Médicine

Striving to vanquish leukemia
March 22,2017, Novartis

'Promising' CML phase I results for ABL001 BCR-ABL inhibitor
December 2016, iCMLf

A Low Concentration of ABL001 Potentiates In Vitro TKI-Induced Bcr-Abl Kinase Inhibition in CML Cells
December 6, 2016, ASH2016

Expanded Phase 1 Study of ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in Patients with CML-Chronic Phase with Failure of Prior TKI Therapy
December 2, 2016, ASH 2016

ABL001 May Be Active, Safe in Chronic Leukemia After Failure of Prior TKI Therapy
December 6, 2015, Cancer Therapy Advisor

ABL001, a Potent, Allosteric Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent Activity in a Phase I Study of Patients with CML with Failure of Prior TKI Therapy
2015, Journal Blood

Bull's-Eyes and Blind Spots: Pre-Clinical Studies with the Allosteric Inhibitor ABL001 in BCR-ABL1 Compound Mutation-Based Resistance
2015, Journal Blood

ABL001, a Potent Allosteric Inhibitor of BCR-ABL, Prevents Emergence of Resistant Disease When Administered in Combination with Nilotinib in an in Vivo Murine Model of Chronic Myeloid Leukemia
2014, Journal Blood
               
                See also Mutation T315I