On December 12th, 2022, the Food and Drug Administration (FDA) approved Krazati (adagrasib) for treatment of non-small cell lung cancer (nsclc) where there is a KRAS G12C mutation. This approval is for patients who have received at least one line of prior treatment such as chemotherapy. The FDA based their approval on the results of the clinical trial KRYSTAL-1 which showed that a high percentage of patients receiving Krazati were more likely to respond to treatment and have a longer duration of response.

Additionally, the FDA also approved the therascreen KRAS RGQ and Agilent Resolution ctDx FIRST tests as companion diagnostics for Krazati. This new approval provides patients whose cancer has a KRAS G12C mutation access to more treatment options.

“KRAS G12C in NSCLC is an area of high unmet need and new treatment options offer patients and our community new hope for survivorship,” said Bonnie J. Addario, co-founder and board chair of GO2 for Lung Cancer. “I’m pleased that patients have options, there’s more awareness of this disease and we are all focused on improving the journeys of people living with lung cancer.”

Read the full FDA release.