Expanded Access Intelligence

Official Statements

Score contribution: 100 1 supporting sources.

Score 1001 references
Featured Reference

At AbbVie, we are passionate about developing advanced therapies to help address the world’s greatest health challenges. We also are committed to providing access to therapies that are not yet approved for use to people who are suffering from a serious or life-threatening illness or condition and might potentially benefit from these products. To do that, AbbVie has developed a Pre-Approval Access to Investigational Products Policy. It outlines important considerations we take into account when evaluating a doctor’s request to use investigational products in a patient with a serious or life-threatening illness or condition.

Active EAPs on ClinicalTrials.gov

Score contribution: 60 7 supporting sources.

Score 607 references
Featured Reference
Expanded Access to ABBV-787Opens in new window

Conditions: Acute Myeloid Leukemia

Conditions: Non-Small Cell Lung Cancer

Conditions: Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma, Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia (ALL), Amyloidosis, Plasma Cell Leukemia

Conditions: Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Conditions: Vanishing White Matter, Cree Leukoencephalopathy

Past EAPs on ClinicalTrials.gov

Score contribution: 40 9 supporting sources.

Score 409 references
Featured Reference

Conditions: Hepatitis C Virus Infection

Conditions: Myelofibrosis, Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma

Conditions: Lymphoma

Conditions: Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)

Conditions: Small Cell Lung Cancer

Conditions: Open-angle Glaucoma

Reagan-Udall Foundation Insights

Additional Information

Single-Patient EA Policies/Criteria ABBV-400 This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Criteria: ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05982873?term=C24-738&rank=1 Venetoclax This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Criteria: ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT03123029?term=C19-920&rank=1 Upadacitinib oral solution This program is designed to provide access to Upadacitinib oral solution prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Criteria:

Mirvetuximab Soravtansine This program is designed to provide access to Mirvetuximab Soravtansine prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Criteria: Elezanumab This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. Criteria: ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04278235?lead=AbbVie&intr=Elezanumab&rank=1 Available Therapies via Single-Patient EA ABBV-400 Advanced histologically or cytologically confirmed solid tumors characterized by MET amplification Elezanumab Acute spinal cord injury Venetoclax Upadacitinib oral solution Mirvetuximab Soravtansine Platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha (FRα) expression Elezanumab – Acute Spinal Cord Injury

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