COMPASSIONATE USE
PROGRAMS
Compassionate use fills a specific gap between trial eligibility and approved options. It is not easy and it is not guaranteed -- but for patients in the right situation, knowing the pathway exists matters.
analyticsAt a Glance
- check_circleCompassionate use allows access to unapproved drugs outside a clinical trial
- check_circleAvailable when no other treatment options exist and the drug is in late-stage trials
- check_circleApplications are made through national regulatory bodies (FDA, EMA, CDSCO, NMPA)
- check_circleCancerFax can support families in identifying compassionate use pathways for specific drugs
How Compassionate Use Works in Practice
Individual (Single-Patient) Compassionate Use
A specific physician submits a request to the drug manufacturer and regulatory body on behalf of one patient. If approved, that patient receives the drug outside the trial context. The physician manages treatment and reporting.
Established Expanded Access Programmes
When a manufacturer receives enough individual requests for the same drug, they sometimes establish a formal programme with pre-specified criteria and standardised application process. More accessible and faster to navigate than individual requests.
Named-Patient Programmes (International)
The European and international terminology for essentially the same access mechanism. Specific requirements and timelines vary by country regulatory framework.
Manufacturer Discretion
Manufacturers are not legally required to provide compassionate access in most regulatory frameworks. Factors in their decision include whether access would undermine ongoing trial enrollment, manufacturing capacity, and the strength of evidence for the specific patient situation.
Frequently Asked Questions
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
Questions About Compassionate Use Access for an Investigational Cancer Drug?
CancerFax helps patients and oncologists identify whether compassionate use or expanded access pathways are viable and assists with the documentation required to pursue them.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified oncologist before making treatment decisions.