EC has cleared Adagrasib as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after a minimum of one prior systemic therapy
Mirati Therapeutics’ building signage. (Credit: Mirati Therapeutics, Inc.)
Mirati Therapeutics has received conditional marketing authorisation from the European Commission (EC) for Krazati (Adagrasib) to treat certain adult patients with advanced non-small cell lung cancer (NSCLC).
Krazati is a highly selective and potent oral small molecule that inhibits KRASG12C.
EC has cleared Adagrasib as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after a minimum of one prior systemic therapy.
The conditional marketing authorisation is valid in all 27 European Union (EU) member states along with Iceland, Norway and Liechtenstein.
This authorisation comes after the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in November 2023.
Mirati Therapeutics founder, president and CEO Charles Baum said: “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.
“Mirati is resolute in our commitment to improve upon treatment options for these patients and looks forward to continued partnership with EU member states to create broad access for all qualified patients.”
According to the US-based biotechnology company, the small-molecule inhibitor has shown a positive benefit-risk profile based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 trial.
KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort study that enrolled 116 patients.
It assessed Krazati 600 mg administered orally twice daily in patients with KRASG12C-mutated advanced NSCLC who were previously administered with a platinum-based regimen and an immune checkpoint inhibitor.
The primary efficacy endpoints were confirmed ORR and DOR as determined by blinded independent central review (BICR) as per the response evaluation criteria in solid tumours.
In December 2022, the US Food and Drug Administration (FDA) granted accelerated approval to Mirati for Krazati to treat KRAS G12C-mutated locally advanced or metastatic NSCLC.