Mirati Therapeutics Submits Marketing Authorization Application to the European Medicines Agency for Investigational Adagrasib as a Treatment for Previously-Treated KRASG12C-mutated Non-Small Cell Lung Cancer

Rhea-AI Summary

Mirati Therapeutics, Inc. (NASDAQ: MRTX) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for adagrasib to treat non-small cell lung cancer (NSCLC) with the KRAS^G12C mutation in patients previously treated with systemic therapy. This submission follows FDA's acceptance of the adagrasib New Drug Application (NDA) for Accelerated Approval. Data from the Phase 2 KRYSTAL-1 study supports the MAA, and detailed results will be presented at the 2022 ASCO Annual Meeting. Adagrasib also has Breakthrough Therapy Designation in the U.S.

Positive

• Submission of MAA for adagrasib is a significant milestone for Mirati.
• Data from Phase 2 KRYSTAL-1 study supports the application.
• Adagrasib has Breakthrough Therapy Designation in the U.S.

Negative

• None.

Submission follows the U.S. FDA acceptance of the adagrasib New Drug Application for the same indication  

SAN DIEGO , May 19, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRAS^G12C mutation who have received at least one prior systemic therapy. 

The MAA is supported by data from the registration enabling cohort of the Phase 2 KRYSTAL-1 study evaluating adagrasib 600mg BID in patients with advanced NSCLC harboring the KRAS^G12C mutation following prior treatment with immunotherapy and chemotherapy, either together or sequentially. The Company reported positive topline data from this cohort in September 2021 and plans to present detailed results at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

"The submission of our application to the EMA is a significant milestone for Mirati and brings us closer to expanding the potential availability of adagrasib to patients with KRAS^G12C-mutated lung cancer in the European Union, if approved," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Therapeutic options for KRAS^G12C-mutated lung cancer are limited, and this submission is an important step forward in our goal to deliver innovative, differentiated therapies in areas of high unmet need. We look forward to working with the EMA to potentially bring this therapy to patients.  We also thank the patients and investigators who make our work possible by participating in clinical trials."

The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRAS^G12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRAS^G12C mutation who have received at least one prior systemic therapy.    

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRAS^G12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRAS^G12C-mutated cancers, as the KRAS^G12C protein regenerates every 24–48 hours. Adagrasib is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS^G12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRAS^G12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

About Mirati Therapeutics, Inc.  
Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet medical need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer. For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook.

Forward Looking Statements
This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati"). Any statement describing Mirati's goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Mirati's drug development pipeline, including without limitation adagrasib (selective KRAS^G12C inhibitor), sitravatinib (TAM receptor inhibitor), MRTX1719 (MTA cooperative PRMT5 inhibitor), MRTX1133 (selective KRAS^G12D inhibitor), and MRTX0902 (SOS1 inhibitor), is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.

Mirati's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati's programs are described in additional detail in Mirati's quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the U.S. Securities and Exchange Commission (the "SEC") available at the SEC's Internet site (www.sec.gov). Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Mirati Contacts: 

Investor Relations: ir@mirati.com  
Media Relations:  media@mirati.com

 

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SOURCE Mirati Therapeutics, Inc.

FAQ

What is the latest submission made by Mirati Therapeutics regarding adagrasib?

Mirati Therapeutics submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for adagrasib for treating KRAS^G12C-mutated non-small cell lung cancer.

What is the status of adagrasib's New Drug Application with the FDA?

The New Drug Application (NDA) for adagrasib is being reviewed by the FDA for Accelerated Approval.

What data supports the MAA submission for adagrasib by Mirati Therapeutics?

The MAA submission is supported by data from the Phase 2 KRYSTAL-1 study evaluating adagrasib in NSCLC patients.

When will detailed results from the KRYSTAL-1 study be presented?

Detailed results from the KRYSTAL-1 study will be presented at the 2022 ASCO Annual Meeting.

What is the significance of the Breakthrough Therapy Designation for adagrasib?

The Breakthrough Therapy Designation indicates that adagrasib has potential for significant improvement over existing treatments for KRAS^G12C-mutated lung cancer.