The FDA has granted accelerated approval to datopotamab deruxtecan (Datroway) for adults with locally advanced or metastatic non-small cell lung cancer that carries an EGFR mutation and has progressed.
Datopotamab deruxtecan, the first TROP2-directed therapy approved for lung cancer in the U.S., showed a 45% response rate in a subgroup from a phase 2 trial, with additional data from a phase 3 trial, according to a June 23 news release from the FDA.
Of 114 patients, 4.4% had a complete response and 40% had a partial response, with a median response of 6.5 months, according to a June 23 news release from the drugmaker.
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