Expanded Access / Compassionate Use
Verastem is a clinical-stage biopharmaceutical company focused on developing therapies to improve the lives of patients diagnosed with cancer in ways that are truly meaningful to them. Our product candidates seek to treat cancer by targeting malignant cells both directly and through modulation of the tumor microenvironment. Our mission is to develop and provide safe, effective and innovative medicines in areas of significant unmet medical need.
Individuals participating in our clinical trials are provided with the treatment being tested. The purpose of these trials is to determine whether the treatment is safe and effective. We submit a full complement of evidence from trials and other data to regulatory authorities, who make the final decision to approve the treatment or not. Until the regulatory authority has made this decision, the treatment remains experimental and is not generally available to patients. However, patients who are not part of these trials and meet certain criteria (see below) can request access, through their physician, to the investigational treatment. This access to investigational product may be called Expanded Access, Compassionate Use, Early Access, Special Access or by other names depending on the country from which the access is being requested.
How does Verastem determine whether to provide an experimental treatment to a patient not in one of our currently active trials?
Each request is evaluated on a case-by-case basis, taking into account a number of considerations. We must consider the condition of the patient, their treatment options and the extent of available human safety and efficacy data on the investigational product. For this and the following reasons, we cannot guarantee that an investigational treatment will be available to a particular patient (or patients).
All of the following criteria must be met for us to consider a request for access to an investigational product:
- The individual has a serious or immediately life-threatening condition, AND
- The individual does not qualify for any ongoing Verastem clinical trials, AND
- The individual has no other viable standard of care treatment options available, AND
- All other relevant medical criteria that would allow for use of the investigational product are met, AND
- A favorable benefit/risk ratio exists for the investigational product based on the most current human clinical data, AND
- There is adequate supply of investigational product to include the use, AND
- Such use is permitted/approved based on the country, region, and /or state-specific legal and regulatory requirements in which the investigational product will be administered, AND
- The licensed treating physician has obtained an Ethical Review Board (ERB) and/or Institutional Review Board (IRB) approval, AND
- Any additional requirements set forth by law/regulation and/or institutional rules and regulations have been met.
How do I make a request?
Requests for access to investigational treatments must be made by your treating physician. We cannot accept requests directly from patients. We will treat every request with respect and dignity, and in a way that protects your privacy. We will consider each request carefully and fairly. Once we have all the necessary information, we will strive to provide our decision as quickly as we can.
For requests coming from all countries, please click on link below; you should receive an acknowledgment we have received your request within 24 hours.
To learn more about our compassionate use program, reach us at firstname.lastname@example.org.
A list of Verastem clinical trials can be found at clinicaltrials.gov.