GlaxoSmithKline - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

Provision of unapproved medicines for unmet medical needs | GSKOpens in new window

“GSK has established programs that may provide an option for providers faced with these challenges. Provision of unapproved medicines under these circumstances may be referred to by various names depending country regulations (e.g. single patient use, named patient use, compassionate use, expanded access, special access, managed access, importation of unlicensed medicine, etc.).”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

Featured Reference

GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation | GSKOpens in new window

As part of the Company’s efforts to ensure physicians and patients are supported during this important time, patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) programme will have the option to enrol in a compassionate use programme to continue to access treatment. Further information on how to enrol patients into the compassionate use program will be provided directly to REMS enrolled prescribers.

Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma | GSKSource

In the US, an expanded access program for belantamab mafodotin is available to eligible patients with multiple myeloma. For patients to be considered for enrollment in the programme, they must be assessed according to specific inclusion and exclusion criteria by their treating physician. Additional information about the expanded access protocol can be found on ClinicalTrials.gov (NCT03763370).

Clinical trials at GSK | GSKSource

[Compassionate use policies and programmes](https://www.gsk.com/en-gb/innovation/trials/provision-of-unlicensed-medicines-for-unmet-medical-needs/ "Our compassionate use policies and programmes")

Vir Biotechnology and GSK start phase 2/3 study of COVID-19 antibody treatment | GSKSource

Potential for initial study results to be available before the end of 2020, with early access to the antibody treatment as soon as the first half of 2021.

GSK to highlight the latest advances in cancer research from across its portfolio and pipeline at ESMO | GSKSource

GSK will also present a real-world analysis of patients with dMMR/microsatellite instability-high (MSI-H) endometrial cancer who received early access to dostarlimab via the temporary authorisation for use (ATU) programme in France, highlighting the need for patient access to new treatment regimens (presentation #553P).

Active EAPs on ClinicalTrials.gov

Score contribution: 60 — 2 supporting sources.

Score 602 references

Featured Reference

Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)Opens in new window

Conditions: Pruritus

Managed Access Program for Combination Treatment With Belantamab Mafodotin in Multiple MyelomaSource

Conditions: Multiple Myeloma

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 5 supporting sources.

Score 405 references

Featured Reference

Compassionate Use for Subcutaneous (SC) BelimumabOpens in new window

Conditions: Systemic Lupus Erythematosus

This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With HypereosinophilicSource

Conditions: Hypereosinophilic Syndrome

Compassionate Use Individual Request Program for GSK525762 in NUT Midline CarcinomaSource

Conditions: Solid Tumours

Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous MelanomaSource

Conditions: Melanoma

Managed Access Program for Momelotinib in MyelofibrosisSource

Conditions: Myelofibrosis, Primary Myelofibrosis

Reagan-Udall Foundation Insights

Company

GlaxoSmithKline

Expanded Access Website

https://www.gsk.com/en-gb/research/our-approach/compassionate-use-expanded-access/

Additional Information

Single-Patient EA Policies/Criteria http://www.gsk.com/media/3368/compassionate-use.pdf Go to GSK Compassionate Use Request Portal at https://gsk-cu-portal.idea-point.com/ to make a request.

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