SpringWorks Therapeutics Compassionate Use Policy
Well-designed clinical trials are the best way to understand a drug’s safety and efficacy. Some patients may be eligible for participation in one of our clinical trials. When a clinical trial is not an option, patients may be able to benefit from a SpringWorks investigational drug through an early access process. The SpringWorks Therapeutics Compassionate Use Policy [[Hyperlinked to full policy]] describes the principles, criteria and regulations that we follow when a physician requests an investigational drug outside of a clinical trial.
SpringWorks Therapeutics may offer Compassionate Use to its investigational therapies to patients in the United States and other countries where SpringWorks Therapeutics intends to submit an application for marketing authorization of the requested product. Physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking access to unapproved medicines.
SpringWorks Therapeutics will only administer Compassionate Use investigational therapies based on the following criteria:
- The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
- The Compassionate Use program is authorized for the requested indication.
- There is meaningful clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
- Providing investigational medicines through Compassionate Use will not compromise clinical trials or the regulatory pathway.
If there are further questions remaining about our guidelines, our full Compassionate Use policy can be read here: Compassionate Use Policy [[Hyperlinked to full policy]]
If you have questions about accessing our clinical trials, please speak with your physician, email us at email@example.com or visit clinicaltrials.gov to learn more.
SpringWorks Therapeutics may update this policy at any time.