AstraZeneca - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

AstraZeneca's Position on Early & Post-Trial Access to MedicinesOpens in new window

“We understand that there are some circumstances where patients around the world with serious or life-threatening conditions, and for whom other treatment options are unavailable, may seek access to a medicinal product before it is approved in their country. For example, if there is no suitable clinical trial (referred to as ‘early access’) or if the patient needs to continue taking a medicinal product after their participation in a clinical trial has finished (referred to as ‘post-trial access’). In such circumstances, we systematically evaluate and, when possible, plan for other appropriate access routes throughout the drug development process, in line with local laws and regulations.”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

Featured Reference

Medicines - Our focus areas - AstraZenecaOpens in new window

We recognise that there are circumstances where patients with serious or life-threatening diseases have exhausted all available therapeutic options and may not be eligible to enrol in one of our clinical trials. In such circumstances individual patients may be eligible for early access to an AstraZeneca investigational medicinal product.

AstraZeneca global resourcesSource

[Early access to AstraZeneca investigational medicinal products](https://www.astrazeneca.com/our-therapy-areas/medicines.html#early)

Imfinzi combined with novel immunotherapies improved clinical outcomes for patients with unresectable, Stage III non-small cell lung cancerSource

Data from a planned analysis of real-world PFS (rwPFS) from the PACIFIC-R observational study was also presented during ESMO, showing the first effectiveness data from over a thousand patients with unresectable, Stage III NSCLC who were treated with Imfinzi in the real-world setting as part of AstraZeneca’s global PACIFIC Early Access Programme.

Template for Standard Operating ProcedureSource

With some exceptions as outlined below, it is important to AZ that publications are not developed using data from case reports, or from patients enrolled in Early Access Programmes. This is because there is the potential to compromise patient privacy or to overstep any Early Access Programme governance, and the generalisability of data from such sources is normally limited. Please refer to AZ Standard “Early Access (EA) to Medicinal Products (MPs)”– see Reference in Section 5. However, for the RDU and Early Oncology, publications may be developed from case reports and early access programmes despite the small numbers of patients involved. Publications from these areas are important in the context of providing information related to the treatment of patients with rare diseases.

TAGRISSO™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancerSource

This approval follows US Accelerated Approval granted in November 2015 and availability in the UK under the Early Access to Medicines Scheme in December 2015.

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 10 supporting sources.

Score 4010 references

Featured Reference

Anifrolumab Early Access ProgramOpens in new window

Conditions: Systemic Lupus Erythematosus

Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in JapanSource

Conditions: PSR Ovarian Cancer With a BRCA Mutation

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further TreatmentSource

Conditions: Non Small Cell Lung Cancer (NSCLC)

An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell LeukemiaSource

Conditions: Relapsed/Refractory Hairy Cell Leukemia

An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and NeckSource

Conditions: Non Small Cell Lung Cancer, Cancer of the Head and Neck

Casodex 150-mg Compassionate Use Trial for Subjects With Prostate CancerSource

Conditions: Adenocarcinoma of the Prostate

Reagan-Udall Foundation Insights

Company

AstraZeneca

Expanded Access Website

https://www.astrazeneca.com/content/dam/az/PDF/AstraZeneca_Policy_on_Early_Access_to_Investigational_Medicines.pdf

Additional Information

Single-Patient EA Policies/Criteria Where there is no MPEAP, AstraZeneca may make an investigational medicine available to a single patient in accordance with country-specific regulations. Terminology and requirements of named patient access schemes vary globally; in the US, for instance this includes the FDA’s guidelines for treatment of individual patients with an Investigational New Drug (IND). (Please review criteria listed on the EA Policy document.) Early Access requests submitted via the online Early Access request platform and e-mails submitted to EarlyAccess@AstraZeneca.com will be acknowledged immediately upon receipt via an automated email reply.

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