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The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.

The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.

David S. Hong, MD

David S. Hong, MD, and David Sommerhalder, MD, discuss the unmet needs for patients with KRAS G12C–mutant non–small cell lung cancer (NSCLC) and colorectal cancer (CRC) that prompted the initiation of the RMC-6291-001 trial; the key efficacy and safety findings with RMC-6291 in patients with NSCLC and CRC; and potential next steps for this agent.