Adagrasib approved conditionally in Europe for pretreated KRAS G12C+ advanced NSCLC
The European Commission has granted conditional marketing authorization to adagrasib (Krazati) for use in adult patients with advanced non–small cell lung cancer (NSCLC) harboring a KRAS G12C mutation whose disease progressed following at least 1 prior systemic treatment
The decision is supported by data from the phase II registration-enabling cohort of the phase 1/II KRYSTAL-1 study (NCT03785249), in which the agent elicited an objective response rate (ORR) of 43% (95% CI, 34%-53%) in evaluable patients (n = 112); this included a complete response rate of 0.9% and a partial response rate of 42%.2 The median duration of response (DOR) was 8.5 months (95% CI, 6.2-13.8), with 58% of patients continuing to respond for at least 6 months.
“Krazati offers an efficacious and tolerable therapeutic option for patients living with advanced KRAS G12C–mutated NSCLC and this approval expands the potential treatment options available,” Martin Reck, MD, PhD, of Lung Clinic Grosshansdorf in Germany, stated in a press release. “With its differentiated profile, Krazati offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in tailoring treatment approaches for patients.”
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