Krazati is forecasted to generate $1.3bn in global sales in 2029, as per GlobalData’s analysis. Image Credit: rafapress / Shutterstock.

Mirati Therapeutics has received conditional marketing authorisation approval for Krazati (adagrasib) from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Krazati targets an altered protein produced by a KRAS-G12C mutation, thereby making it inactive. It has received accelerated approval by the US Food and Drug Administration (FDA) as a second-line treatment for adult patients with KRAS-G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Krazati is forecasted to generate $1.3bn in global sales in 2029 while Amgen’s KRAS inhibitor Lumakras (sotorasib) is forecasted to earn $1bn in global sales in the same period, as per GlobalData’s analysis. However, an FDA Advisory Committee (Adcom) voted against the drug’s full approval in NSCLC.

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The conditional approval was based on data from the open-label Phase I/II trial (NCT03785249), as per a 3 November press release. In September, Mirati presented two-year follow-up data from the trial, which showed a median overall survival (OS) of 14.1 months.

In July, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for the conditional marketing authorisation application (MAA) for Krazati. According to the CHMP, while the drug had a positive risk-benefit profile, it did not fulfil certain requirements for issuing an MAA. Mirati has since requested a formal re-examination of the conditional MAA, as per the company’s Q2 financials.

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A confirmatory Phase III study (NCT04685135) evaluating Krazati in previously treated patients with KRAS-G12C mutated NSCLC is ongoing. The trial compares the drug with a standard chemotherapy, docetaxel.

Last month, Bristol Myers Squibb entered a definitive merger agreement to acquire Mirati, which will expand its oncology portfolio. The multi-billion-dollar deal is expected to close by H1 2024.