Information about Revolution Medicines’ pre-approval access pathways for investigational medicines outside of clinical trials.

At Revolution Medicines, Inc, we are committed to developing safe and effective targeted therapies for patients with RAS-driven cancers.

We conduct controlled clinical trials to evaluate the safety and efficacy of our investigational product candidates. Clinical trials are carefully designed research studies in humans that determine whether a potential therapy is safe and effective.

We encourage patients and physicians to explore participation in clinical trials whenever possible. Information about Revolution Medicines-sponsored clinical trials can be found at www.clinicaltrials.gov by searching “Revolution Medicines.”

We recognize, however, that not all patients are able to participate in a clinical trial. In limited circumstances, eligible patients may be able to access investigational medicines outside of a clinical trial through pre-approval access pathways.

The availability of these pathways depends on applicable laws and regulations, product supply, and operational feasibility. Pre-approval access is intended to complement, not replace, clinical trials. Accordingly, where an appropriate clinical trial is available and a patient is eligible to participate, clinical trial participation will generally remain the preferred option over pre-approval access.

What is Pre-Approval Access?

Pre-approval access refers to regulatory pathways that may allow eligible patients with serious or life-threatening conditions to gain access to investigational medicines outside of a clinical trial before the investigational medicine has received local regulatory approval.

These pathways are intended for patients who are unable to participate in a clinical trial and who have exhausted all other appropriate treatment options.

Because pre-approval access is governed by country-specific laws and regulations, patients may be able to access investigational medicines through different regulatory pathways depending on their country.

Unlike clinical trials, the primary purpose of pre-approval access is treatment, not research. These pathways are not intended to generate clinical data and do not replace participation in clinical trials.

Access to investigational medicines through pre-approval access pathways typically requires some or all of the below:

A request and/ or approval from the treating physician,
Approval from the sponsoring company (e.g. Revolution Medicines)
Compliance with applicable regulatory requirements, including authorization from health authorities where required (such as the U.S. Food and Drug Administration)
Ethics committee or institutional review where required by local law.

Our Approach to Pre-Approval Access

Revolution Medicines is committed to helping eligible patients access investigational medicines as responsibly and efficiently as possible while advancing clinical development and pursuing regulatory approvals.

When evaluating pre-approval access pathways, Revolution Medicines seeks to ensure that:

Patient safety is prioritized
Access does not interfere with ongoing clinical trials
Regulatory requirements and applicable local laws are met

Pre-approval access pathways are only available for specific investigational products as determined by Revolution Medicines, where applicable, in accordance with regulatory requirements. Currently, pre-approval access is available only for the investigational products explicitly listed below. We believe that access to our investigational products should generally be limited to controlled clinical trials until their safety, tolerability, and effectiveness have been adequately established.

Revolution Medicines may make pre-approval access available only for specific investigational medicines, where appropriate and in accordance with applicable regulatory requirements.

If you have questions about Revolution Medicines’ pre-approval access, please contact us at medinfo@revmed.com.

For currently available pre-approval access pathways offered by Revolution Medicines, please see:

Available Pre-Approval Access Pathways

For information regarding closed or previously available access pathways, please see:

Closed Pre-Approval Access Pathways

Pre-Approval Access to Investigational Medicines

Pre-Approval Access to
Investigational Medicines