None listed
Conditions
Keywords
Named Patient Program
Brief summary
This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.
Detailed description
Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.
Interventions
DRUGOlverembatinib
Oral Olverembatinib
Sponsors
Tanner Pharma Group
Ascentage Pharma Group Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Inclusion criteria
• Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.
Exclusion criteria
* Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures * Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis * Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease * Existing conditions of severe liver malfunction * Existing conditions of severe myelosuppression * Existing conditions of severe hemorrhage * Pregnant or baby feeding
Contacts
Primary ContactTanner Pharma
Backup ContactNPP Core working Group
Outcome results
None listed