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 designed to fully answer important scientific questions about the potential risks and benefits of our investigational drugs, and to obtain regulatory approval. Patients entering our clinical trials are required to meet specific eligibility criteria. Not every patient who wishes to take part in a clinical trial will meet the eligibility criteria. When a patient does not meet the eligibility criteria, or if a clinical trial is not available, and the patient has exhausted available treatment options, Mirati may consider providing access to its investigational medicines outside of a clinical trial through a process called Expanded Access.
Please note, however, that Mirati does not currently provide access to its investigational medicines outside of enrollment in clinical trials.
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 outside of a clinical trial should contact Mirati through the contact information above, to make the request on behalf of the patient.
Anticipated Timing: Mirati will acknowledge receipt of any Expanded Access questions or requests 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, please visit www.clinicaltrials.gov.