Clinical Trials Arena

European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC

Mirati filed a marketing authorisation application to the EMA for Krazati for patients within this indication in May 2022.

Mirati Therapeutics has received conditional marketing authorisation from the European Commission for Krazati (adagrasib), a targeted treatment for patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC).

Mirati filed a marketing authorisation application to the European Medicines Agency (EMA) for Krazati in this indication in May 2022. In November 2023, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation to the therapy.

In October 2023, pharma-giant Bristol Myers Squibb acquired Mirati for a total value of $4.8bn. The deal is expected to close by the end of Q1 2024. Krazati was the company's lead marketed drug and significant driver for potential revenues.

According to GlobalData’s Pharma Intelligence Center, Krazati is forecast to generate $1.24bn in sales in 2029.

GlobalData is the parent company of Clinical Trials Arena.

Krazati is a small molecule RAS inhibitor which suppresses cancer cell signalling and prevents cell proliferation by inhibiting mutant KRAS, a signalling protein which acts as a molecular power switch. One of Krazati’s main competitors, Amgen’s Lumakras (sotorasib), won an accelerated approval for the same indication. Amgen received negative feedback from the US Food and Drug Administration’s (FDA’s) Drug Advisory Committee last year due to Phase lll progression-free survival data that was deemed unreliable. Later in December, the FDA issued a complete response letter specifying that Amgen would need to conduct a confirmatory study before February 2028 in order to bag a traditional approval.

The latest authorisation is based on positive results from the Phase II cohort of the registrational KRYSTAL-1 study (NCT03785249) in NSCLC patients who progressed after at least one prior systemic therapy. In the 116-patient cohort that assessed Krazati at a 600mg dosage, an overall response rate (ORR)–the trial's primary endpoint– of 43% was reported.

In the announcement accompanying the authorisation, Martin Reck of the German lung clinic Grosshansdorf in Germany said: “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.”