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Adagrasib (MRTX849)

Manufactured By:
Mirati Therapeutics
3545 Cray Court
San Diego CA 92121
United States

858-332-3410

www.mirati.com

Adagrasib (MRTX849) is a potent, highly selective and orally available small molecule inhibitor of a form of KRAS that harbors an oncogenic substitution mutation (G12C). KRAS G12C is a well-validated driver mutation present in approximately 14% of NSCLC adenocarcinoma patients and 5% of CRC patients. 

Adagrasib has demonstrated broad-spectrum antitumor activity across a panel of KRAS G12C-positive patient- and cell-derived in vivo tumor models, including complete tumor regression in a subset of these models. MRTX849 is now in the clinic and has the potential to provide a long-awaited targeted therapy option for patients exhibiting a KRAS driver mutation.

Mirati has made adagrasib (MRTX849) available through and intermediate expanded access protocol (NCT 05162433) for patients ineligible for a clinical trial of adagrasib (MRTX849).  Additional information is available here.

Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
  • Confirmed presence of a KRASG12C mutation
  • Ineligible for an ongoing clinical trial of MRTX849
  • No available or not eligible for standard of care treatment
  • Adequate organ function
  • CNS Metastases (within set parameters) are allowed
  • ECOG performance status of ≤ 2

Exclusion Criteria:

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
  • Prior therapy targeting a KRAS G12C mutation
  • Other active cancer

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 MRTX849 must do so via their physician.  A licensed physician who believes their patient may benefit from access to MRTX849   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 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 for the indication 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.  

For information on Mirati clinical trials, please visit ClinicalTrials.gov or visit Mirati Clinical Trials.


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