Mirati Therapeutics has obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency for Krazati (adagrasib) to treat KRASᴳ¹²ᶜ-mutated advanced non-small cell lung cancer (NSCLC).
Krazati is indicated for usage as a targeted therapy option in patients with a minimum of one previous systemic therapy whose disease advanced following treatment.
An oral small-molecule KRASᴳ¹²ᶜ inhibitor, Krazati penetrates the central nervous system.
It recently received accelerated approval (Subpart H) from the US Food and Drug Administration (FDA).
In early November 2023, Krazati received conditional marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
This therapy is currently being analysed as a single agent and with other anti-cancer treatments for advanced KRASᴳ¹²ᶜ-mutated solid tumours, including NSCLC, pancreatic and colorectal cancers.
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The open-label Phase I/II KRYSTAL-1 trial is assessing adagrasib alone or as a combination regimen for advanced KRASᴳ¹²ᶜ-mutated solid tumours.
Mirati Therapeutics chief medical officer Alan Sandler stated: “The positive opinion from the CHMP for Krazati marks an important step on the path to providing access to a potentially best-in-class therapeutic option to patients living with this difficult-to-treat disease.
“We look forward to approval from the European Commission and the opportunity to positively impact the lives of eligible patients living in the European Union.”
