Mirati Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Investigational Adadagrasib as a Treatment for Previously Treated KRASG12C Mutated Non-Small Cell Lung Cancer
Submission follows US FDA acceptance of adagrasib New Drug Application for same indication
SAN DIEGO , May 19, 2022 /PRNewswire/ — Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that it has filed a Marketing Authorization Application (MA) with the European Medicines Agency (EMA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring KRASG12C mutation who have received at least one prior systemic therapy.
The Marketing Authorization is supported by data from the cohort allowing registration of the phase 2 KRYSTAL-1 study evaluating adagrasib 600 mg BID in patients with advanced NSCLC harboring KRASG12C mutation following previous treatment with immunotherapy and chemotherapy, together or sequentially. The company reported positive early results 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.
“Submitting our application to EMA is an important milestone for Mirati and brings us closer to expanding the potential availability of adagrasib to patients with KRASG12C-mutated lung cancer in the European Union, if approved,” said Charles BaumMD, Ph.D.President, Founder, and Head of Research and Development, Mirati Therapeutics, Inc. “Therapeutic Options for KRASG12C-mutated lung cancer are limited, and this submission is an important step forward in our goal to provide innovative and 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 researchers who make our work possible by participating in clinical trials.”
the adagrasib The New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for expedited approval (Subpart H) as a treatment for patients with NSCLC harboring KRASG12C 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 to ensure that safe and effective treatments are made available to the most patients. as soon as possible. Adgrasib also earned Breakthrough Therapy designation in the United States as a potential therapy for patients with NSCLC harboring KRASG12C mutation who have received at least one prior systemic therapy.
On Adgrasib (MRTX849)
Adgrasib is an investigational, highly selective and potent oral small molecule inhibitor of KRASG12C which is optimized to maintain target inhibition, an attribute that could be important in treating KRASG12C-mutated cancers, such as KRASG12C the protein regenerates every 24 to 48 hours. Adgrasib is being evaluated as monotherapy and in combination with other cancer treatments in patients with advanced KRASG12C– mutated solid tumours, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information, visit Mirati.com/science.
Mirati has an Extended Access Program (EAP) for adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about 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 cancer patients and their loved ones. The company is relentlessly focused on developing therapies that address high unmet medical needs, including lung cancer, and advancing a pipeline of novel therapies targeting the genetic and immunological drivers of cancer . Unified for patients, Mirati’s vision is to unleash the science behind the promise of life beyond cancer. For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook.
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 commercial potential of Mirati’s drug development pipeline, including without limitation adagrasib (Selective KRASG12C inhibitor), sitravatinib (TAM receptor inhibitor), MRTX1719 (MTA PRMT5 cooperative inhibitor), MRTX1133 (selective KRASG12D 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, in particular the challenges inherent in the process of discovering, developing and commercializing safe and effective new drug products for human therapeutic use, and in the effort to create a company around these drugs.
Mirati’s forward-looking statements also involve assumptions which, if they never materialize or prove to be incorrect, 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, such statements are based solely on facts and factors currently known to Mirati. Accordingly, you are cautioned not to rely on these forward-looking statements. These and other risks relating to Mirati’s programs are described in more detail in Mirati’s Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, which are filed with the United States Securities and Exchange Commission. States (the “SEC”) available at the SEC’s website (www.sec.gov). Mirati undertakes no obligation to update any 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.
Show original content to download multimedia:https://www.prnewswire.com/news-releases/mirati-therapeutics-submits-marketing-authorization-application-to-the-european-medicines-agency-for-investigational-adagrasib-as-a-treatment-for- transferred-non-small-cell-lung-cancer-krasg12c-previously-treated-301551654.html
SOURCE Mirati Therapeutics, Inc.