Krazati is being analysed as a single agent and with other anti-cancer treatments for advanced KRASG12C-mutated solid tumours, such as NSCLC. Credit: 15Studio / Shutterstock.com.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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).

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”