Expanded Access Policy
Nuvalent is committed to researching and developing novel new drug candidates that are highly selective to bring precisely targeted therapies to patients with cancer. Our goal at Nuvalent is to ensure the safety and efficacy of our investigational therapies and advance them through the clinical trial and regulatory processes with a sense of responsible urgency. It is through clinical trials and the regulatory review and registration process with regulators that will make our therapies more widely available for patients who need them. Nuvalent encourages patients to speak with their treating physicians about treatment options and, when possible, participate in clinical trials.
We understand that there may be certain circumstances when a patient may not meet the eligibility criteria to participate in a clinical trial and may have exhausted all available treatment options. At this time, Nuvalent remains committed to delivering our commitment to patients through participation in our clinical trials and does not have an expanded access program (EAP) that allows patients to have access to our investigational drug candidates outside of enrollment in our clinical trials. Clinical trials, and the subsequent approval of a new therapeutic option, provide the best path to ensure long-term access to treatment. We encourage you to stay informed regarding our development programs and, as more information and clinical data on the safety and efficacy of our investigational therapies become available, our policy on expanded access will be reviewed.
If you have any questions regarding this policy, please contact firstname.lastname@example.org. Nuvalent plans to respond to EAP inquiries within 7 business days.