On June 23, 2025, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of Datroway (datopotamab deruxtecan-dlnk) for people with locally advanced or metastatic EGFR-positive non-small cell lung cancer (NSCLC) who have previously received EGFR-targeted therapy and chemotherapy.
This latest approval is based on the results of the TROPION-Lung01 and TROPION-Lung05 studies, which looked at how safe and effective Datroway (datopotamab deruxtecan-dlnk) is for people with EGFR-positive NSCLC who received prior treatment with an EGFR-targeted therapy and chemotherapy. The studies showed a promising response rate and responses that lasted a meaningful amount of time for participants in both trials. This is encouraging news for people who have progressed on multiple previous lines of therapy and may have limited treatment options.
Datroway (datopotamab deruxtecan-dlnk) is a type of treatment known as an antibody-drug conjugate (ADC). ADCs bind directly to a target on the cancer cells, delivering a powerful drug that causes them to die.
Please speak with your healthcare team for more information about Datroway (datopotamab deruxtecan-dlnk) to see if it may be a good 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.
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