On January 10, 2024 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported that the European Commission (EC) granted conditional marketing authorization for KRAZATI (adagrasib) as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy (Press release, Mirati, JAN 10, 2024, View Source [SID1234639189]).
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KRAZATI has demonstrated a positive benefit-risk profile based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor. The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST v1.1).
"KRAZATI offers an efficacious and tolerable therapeutic option for patients living with advanced KRASG12C -mutated NSCLC and this approval expands the potential treatment options available," Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany. "With it’s differentiated profile, KRAZATI offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in tailoring treatment approaches for patients."
Conditional marketing authorization for KRAZATI is valid in all 27 EU member states plus Iceland, Norway and Liechtenstein. This authorization follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in November 2023.
"This is a meaningful day for patients living with this difficult-to-treat cancer in the European Union as we can now offer a differentiated and potentially best-in-class therapeutic option to this underserved population," Charles Baum, M.D., PhD, founder, president and chief executive officer, Mirati Therapeutics, Inc., "Mirati is resolute in our commitment to improve upon treatment options for these patients and looks forward to continued partnership with EU members states to create broad access for all qualified patients."
Mirati thanks the patients, physicians, investigators and site coordinators who participated in the clinical trials that led to this important approval.
Important Safety Information
The Summary of Product Characteristics (SmPC) for KRAZATI (adagrasib) will be available from the European Medicines Agency at the Union Register of medicinal products.
About KRAZATI (adagrasib)
Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C.
Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours.1 Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.2-34
The FDA provided KRAZATI Accelerated Approval (Subpart H), allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints.
Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer. For more information, visit Mirati.com/science.
About the KRYSTAL-1 Study
KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRASG12C mutation.
About KRASG12C in NSCLC
Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.