Expanded Access Policy

Effective March 22, 2023

Revolution Medicines, Inc. (RevMed) is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. We conduct clinical trials to evaluate the safety and efficacy of investigational product candidates. Clinical trials are controlled research studies in humans designed to determine if an investigational product candidate is safe and effective. RevMed encourages awareness of and participation in our clinical trials. For information regarding RevMed-sponsored clinical trials, please visit www.clinicaltrials.gov and search for Revolution Medicines to view clinical trials sponsored by RevMed. Our current focus is to complete our ongoing clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of our investigational product candidates.

Prior to regulatory approval by the U.S. Food and Drug Administration (FDA) and foreign regulatory authorities, patients gain access to investigational treatments, including RevMed’s product candidates, by participating in clinical trials. In certain cases, when it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, a patient’s doctor may attempt to seek special access to an investigational product candidate for that patient outside of a clinical trial. This is known, among other terms, as expanded access or compassionate use. For a patient to obtain access to an investigational product candidate through expanded access, the patient’s physician, the drug’s sponsor and the regulatory authority in the physician’s country of practice (e.g., the FDA in the US) must all approve the use. Unlike the use of an investigational new drug in a clinical trial setting, the primary purpose of expanded access is to use the investigational drug for patient treatment purposes, rather than to gather data on safety, tolerability and effectiveness.

Currently, RevMed does not offer an expanded access program. We believe that access to our investigational product candidates should be limited to controlled clinical trials until such time as their safety, tolerability and effectiveness have been determined and confirmed by regulatory authorities. In addition, there are regulatory constraints placed upon expanded access programs (for US guidelines see https://www.fda.gov/news-events/public-health-focus/expanded-access). Access to our product candidates before dose and dosing regimen have been optimized and safety and tolerability have been confirmed may not be in the best interests of patients.

Accordingly, while clinical trials are ongoing, we believe participation in our clinical trials is the only safe and appropriate way to access our investigational product candidates.

If you have questions about RevMed’s expanded access policy, please contact us at 
CT-inquiries@revmed.com.

RevMed may revise this policy at any time.