Expanded Access Programs

People living with cancer need more options – right now. Let’s unleash
the possibilities.

Access policy

SpringWorks Therapeutics is committed to developing safe and effective therapies for patients with severe rare diseases and cancer. We believe that, wherever possible, use of an investigational or unlicensed therapy for a patient as part of a clinical trial is preferable because clinical trials are designed to generate comprehensive safety and efficacy data that may lead to the approval of new medicines and, consequently, to wider availability for patients in need.

In cases when a patient may not qualify for a clinical trial, there may be no trials available, or a patient has exhausted all available treatment possibilities, SpringWorks may be able to provide access to eligible patients under the supervision of the requesting healthcare provider (HCP) through either our named patient program or our compassionate use program. This refers to the use of a SpringWorks investigational or unlicensed therapy outside of our clinical trials and prior to its commercial availability.

Criteria for considering a request for named patient/ compassionate use access

SpringWorks is committed to reviewing all requests for named patient and compassionate use access in line with criteria consistent with international, regional, and local regulatory authorities. The following criteria – but not limited to the below – must be met by the individual patient, the requesting HCP, and the SpringWorks investigational or unlicensed therapy for a request to be considered.

Patient

  • The patient has a serious, debilitating, or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
  • The patient does not qualify to participate in an ongoing clinical trial sponsored by SpringWorks in an accessible geographical location.

Investigational or unlicensed therapy

  • The request, if approved, will not interfere with clinical trials that could support an investigational or unlicensed therapy’s development or marketing approval for the treatment indication.
  • Sufficient clinical data are available for both the disease condition and mechanism of action of the investigational or unlicensed therapy and such data indicate that the potential benefits of access to the investigational or unlicensed therapy outweigh any known potential risks.
  • There is an adequate supply of the investigational or unlicensed therapy to support the request and such supply will not negatively impact a clinical trial or product anticipated for product launch or other required purposes.

Healthcare provider

  • The HCP must be currently licensed and have prescriptive authority.
  • The HCP must follow applicable regulations in his/her country depending on the route of access, including submission to their local Investigational Review Board (IRB) or Ethics Committee (EC) as required.
  • The HCP must obtain informed consent from the patient or his/her legal guardian(s) and report safety events.
  • The HCP must oversee the patient’s treatment and supervise administration of the investigational or unlicensed therapy in accordance with SpringWorks defined access criteria (which in some countries may include a protocol for treatment use).

Making a request for expanded access/ compassionate use

Requests for access to a SpringWorks investigational or unlicensed therapy must be made voluntarily by the patient’s treating HCP. Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.

To request access, HCPs should send an email to medinfo@springworkstx.com.

We are committed to evaluating all requests for named patient or compassionate use access in a fair and equitable manner. SpringWorks will acknowledge requests from licensed HCPs as soon as possible, generally within two business days of receipt and a decision will be made and communicated as soon as possible thereafter. SpringWorks cannot guarantee that all access requests will be granted, even when eligibility criteria are met.

Any named patient or compassionate use access to investigational or unlicensed therapies must comply with the applicable country-specific laws and regulations, including importation requirements, approvals from applicable regulatory bodies and by an appropriate Institutional Review Board or Ethics Committee. SpringWorks may require agreements and/or certifications executed by the treating HCP and other information to be provided prior to final approval of any request.

Patients and caregivers seeking information about access to our investigational or unlicensed therapies, either through a clinical trial or through named patient program or compassionate use program, should consult with their treating HCP.

SpringWorks may revise this Policy at any time in line with the 21st Century Cures Act, or other laws or regulations as applicable.