Expanded Access Policy
Expanded Access to Investigational Medicines Prior to Regulatory Approval
Mirati Therapeutics, Inc. (Mirati) is a 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 patients with serious or immediately life-threatening diseases or conditions access to our investigational therapies at the appropriate time and in the most clinically appropriate manner.
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.
Europe, UK, Switzerland
Mirati has an Expanded Access Program for its investigational drug adagrasib for the treatment of adult patients with KRASG12C-mutated cancers in the European Economic Area, United Kingdom and Switzerland. Patients are only eligible for this program if they are ineligible for the available standard of care in the given country or for available actively enrolling clinical trials for adagrasib, and after obtaining applicable country regulatory approvals.
Requesting information: Appropriate patients, who are ineligible or unable to participate in any actively enrolling clinical trials for adagrasib, interested in obtaining access to adagrasib must do so via their physician. A licensed physician who believes their eligible patient may benefit from access to adagrasib should utilize the contact information below to make the request on behalf of the patient.
Mirati will acknowledge receipt of any questions or requests received through our Expanded Access partner, Inceptua, from licensed physicians within one (1) business day of receipt. Making a request does not guarantee the granting of access to adagrasib by Mirati.
In the United States, the Mirati & Me Patient Support Program offers comprehensive support services for eligible patients, caregivers, and healthcare professionals, including personalized education and financial resources to help appropriate patients who have been prescribed Mirati medications. Learn more by visiting the Mirati & Me website or 1-844-647-2842.
Access to other investigational agents
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.
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, please visit www.clinicaltrials.gov.