FDA D.I.S.C.O. Burst Edition: FDA approvals of Augtyro (repotrectinib) for NTRK gene fusion-positive solid tumors and Krazati (adagrasib) for KRAS G12C-mutated colorectal cancer

Adagrasib is a highly specific and potent oral KRAS G12C inhibitor, optimized for durable target inhibition. This characteristic may be important for treating cancers with KRAS G12C mutations, as the KRAS G12C protein regenerates every 24-48 hours. Adagrasib has a long 24-hour half-life and broad tissue distribution, and it can cross the blood-brain barrier, helping to maximize drug efficacy. Adagrasib is approved by the FDA for the treatment of previously treated non-small cell lung cancer (NSCLC) and colorectal cancer harboring KRAS G12C mutations...

In 2022, adagraxibu, a prescription drug targeting KRAS G12C, received accelerated approval from the FDA in the United States. Patients should strictly follow their doctor's instructions.

Repotrectinib is a next-generation tyrosine kinase inhibitor that targets the ROS1 and NTRK oncogenic factors. Patients with solid tumors (including NSCLC) carrying ROS1 and NTRK gene fusions often develop resistance mutations after receiving currently approved targeted therapies. These mutations limit the binding of drugs to their targets, ultimately leading to tumor progression.

Ripretinib is a prescription drug that targets ROS1 and NTRK1/2/3. It was approved in the United States in November 2023 for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer. On June 13, 2024, it was approved by the FDA for the treatment of NTRK-positive locally advanced or metastatic solid tumors. It should be used in strict accordance with the doctor's instructions.