Chronic Myeloid Leukemia | Topics

 
European Commission Approves Asciminib in Philadelphia Chromosome–Positive CML
August 29, 2022

Results from the phase 3 ASCEMBL trial led to the approval of asciminib by the European Commission for patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Asciminib Yields Long-Lasting MMRs in Previously Treated CML-CP
June 10, 2022

Findings from the phase 3 ASCEMBL trial indicated that asciminib as a treatment for chronic myelogenous leukemia in chronic phase could represent a new standard of care.

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

Improvement in major molecular response rate and depth of response coupled with a favorable safety profile were noted with asciminib vs bosutinib in patients with chronic-phase chronic myeloid leukemia.

Promising Activity Observed With Ponatinib Treatment in T315I-Mutated CP-CML
December 12, 2021

In a population of patients with chronic myeloid leukemia with resistant disease experienced promising activity following treatment with ponatinib regardless of T315I mutation status.

Asciminib Granted Accelerated Approval by FDA for Ph+ Chronic Myeloid Leukemia in 2 Indications
October 29, 2021

The FDA granted accelerated approval to asciminib for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia for 2 indications.

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

The FDA has granted breakthrough therapy designation to asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who have been previously treated with 2 or more tyrosine kinase inhibitors; or who harbor the T315I mutation.

FDA Approves Ponatinib To Treat Adult Patients with Resistant/Intolerant Chronic-Phase CML
December 19, 2020

The FDA approved the supplemental new drug application for ponatinib (Iclusig) to treat patients with chronic-phase chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

Study Finds Treatment-Free Remission Not Impaired by Low-Dose TKIs for Patients with CML
September 09, 2020

Researchers found that long-term treatment-free remission was not impaired by low-dose TKI regimens for patients with chronic myeloid leukemia.

Phase 3 ASCEMBL Study Meets Primary End Point In Patients with CML
August 26, 2020

The study is evaluating asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who were previously treated with 2 or more tyrosine-kinase inhibitors.

FDA Grants Orphan Drug Designation to HQP1351 for Chronic Myeloid Leukemia
May 05, 2020

The FDA granted orphan drug designation to Ascentage Pharma’s HQP1351 for the treatment of chronic myeloid leukemia.