Expanded Access Policy

Nuvalent is committed to researching and developing novel new drug candidates that prioritize selectivity in order to minimize adverse events, drive durable responses, and ultimately 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 follows that we expect to 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 appropriate given their condition, 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 investigational therapies to patients through clinical trials and does not have an expanded access program that would allow patients to have access to our investigational drug candidates outside of enrollment in our clinical trials. This includes requests for pre-approval access under section 561(b) of the Federal Food, Drug, and Cosmetic Act, the Right to Try Act of 2017 (Pub. L. No. 115-176), and any analogous state laws. We believe that clinical trials, and the subsequent approval of a new therapeutic option, provide the best path to ensure long-term, equitable 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 may be revisited. Any changes to this policy will be posted to this site.

You can find information about ongoing clinical trials of our drug candidates at https://nuvalent.com/pipeline/ or by visiting clinicaltrials.gov and entering “Nuvalent” in the “other terms” search box. If you have any questions regarding this policy, please contact info@nuvalent.com. Nuvalent plans to respond to inquiries about this policy within 7 business days.