By webmin on
Email
AbbviePAA@abbvie.com
NCT Name
NCT03123029; NCT05982873; NCT04278235
Acknowledgement
1 business day
EA Page
https://www.abbvie.com/who-we-are/access-to-investigational-drugs-policy.html
Sponsor
AbbVie
EA Therapies for Single Patient

ABBV-400

Advanced histologically or cytologically confirmed solid tumors characterized by MET amplification

Elezanumab

Acute spinal cord injury

Venetoclax

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

Upadacitinib oral solution

  • Ulcerative colitis
  • Crohn’s disease
  • Juvenile idiopathic arthritis (including sJIA, pJIA or JPsA)
  • Atopic dermatitis

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

EA Policies for Single Patient

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:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

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:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

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:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

 

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:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

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:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04278235?lead=AbbVie&intr=Elezanumab&rank=1

Expanded Access Listings

Expanded Access to Telisotuzumab Vedotin

Conditions
Non-small Cell Lung Cancer (NSCLC)

This is an expanded access program (EAP) for eligible participants. This program isdesigned to provide access to Telisotuzumab vedotin prior to approval by the localregulatory agency. Availability will depend on territory eligibility. A medical doctormust decide whether the potential benefit outweighs the risk of receiving aninvestigational therapy based on the individual patient's medical history and programeligibility criteria.