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FDA Updates Approval for Retevmo (selpercatinib) in RET-Positive NSCLC

July 15, 2026

Did you know? RET is a gene found in healthy cells that is important for their growth and survival. In some people, the RET gene joins, or fuses with a different gene. This causes the cells to grow out of control, causing cancer. When this happens in the lung, it is called RET-positive non-small cell lung cancer (NSCLC), which occurs in about 2 out of every 100 cases (2%) of lung cancer.

On July 14, 2026, the U.S. Food and Drug Administration (FDA) updated its accelerated approval of Retevmo (selpercatinib) to a traditional approval. Retevmo (selpercatinib) is now approved for people with locally advanced or metastatic solid tumors, including NSCLC, with a RET gene fusion, following prior systemic treatment such as chemotherapy.

Retevmo (selpercatinib) received accelerated approval for this population in May 2020. Updating the drug to “traditional” approval means that the FDA is satisfied the drug's previously predicted clinical benefit has been verified by further studies. The update does not change Retevmo’s (selpercatinib’s) availability or day-to-day usage.

This latest approval is based on the results of the LIBRETTO-001 study, which looked at how safe and effective Retevmo (selpercatinib) is for people with locally advanced or metastatic solid tumors with a RET gene fusion, following prior systemic treatment such as chemotherapy. The study showed participants in the trial experienced both a promising response rate and benefits lasted for a meaningful time period in those who responded.  

This is an exciting update, as Retevmo (selpercatinib) verified clinical benefit may help to inform discussions with your healthcare team about which RET-targeting treatment may be best for you.

Please speak with your healthcare team for more information about Retevmo (selpercatinib) and to see if it may be an option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.  

Read the full FDA announcement.