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 correct 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 products, and to obtain regulatory approval. Patients entering 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.
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 medicine outside of a clinical trial should contact Mirati through the contact information above, to make the request on behalf of the patient. Information on the currently-available expanded access protocol with adagrasib (MRTX849) is available on clinicaltrials.gov NCT 05162433.
Anticipated Timing: Mirati will acknowledge receipt of any Expanded Access questions or request 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. If approved, the Expanded Access supply of investigational medicine may be continued until the drug is approved for use through the local healthcare system, or until, in the opinion of the treating physician, there is no treatment benefit. However, Mirati cannot guarantee drug supply. Mirati reserves the right to restrict access or discontinue the Expanded Access investigational drug at any time.
In the U.S. physicians may find additional information on Compassionate Use 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.
Updated: 17 December 2021