Named Patient Program for Olverembatinib (HQP1351)

Ascentage Pharma Group

Status

Treatments: Drug: Olverembatinib

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT05594758

NPP Olverembatinib

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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