Expanded Access Policy
Expanded Access to Investigational Medicines Prior to Regulatory Approval
Mirati Therapeutics, Inc. (Mirati) is a clinical-stage biotechnology company dedicated to advancing safe and effective novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer.
Our goal is to provide access to our investigational therapies at the appropriate time and in the most clinically appropriate manner for patients.
Patients are at the center of our clinical programs, which are designed to answer important scientific questions about the potential risks and benefits of our investigational drugs, and to obtain regulatory approval.
Mirati has an Expanded Access Program for its investigational drug adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the United States.
We do not currently provide access to our other investigational medicines outside of enrollment in clinical trials. If you have questions about our programs or eligibility for our clinical trials, please contact us.
Contact Information: A treating physician may submit questions or requests regarding Expanded Access by contacting the Mirati Call Center 1-475-522-2200 or by emailing Mirati.ExpandedAccess@earlyaccesscare.com.
Request Procedure: Patients interested in obtaining access to a Mirati investigational therapy must do so via their physician. A licensed physician who believes their patient may benefit from access to a Mirati investigational therapy should contact us through the contact information above to make the request on behalf of the patient.
Anticipated Timing: Mirati will acknowledge receipt of any questions or requests received through our Expanded Access center from licensed physicians within one (1) business day of receipt. Making a request does not guarantee the granting of access to an investigational drug by Mirati.
In the U.S. physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians.
Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
For information on Mirati clinical trials and the Adagrasib (MRTX849) Expanded Access Program, please visit www.clinicaltrials.gov.