Managed Access Programs for ABL001, Asciminib

Launched by NOVARTIS PHARMACEUTICALS · Apr 21, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. An independent request was received from a licensed physician.
• • 2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
• • 3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
• • 4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
• • 5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
• • 6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
• • 7. Managed Access provision is allowed per local laws/regulations