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Roche announced today that the European Commission has conditionally approved Rozlytrek for the treatment of patients with NTRK gene fusion in patients aged 12 and over.
the European Commission also approved Rozlytrek for the treatment of ROS1-positive, advanced non-small cell lung cancer (NSCLC) patients previously not treated with ROS1 inhibitors. "This approval represents another important step forward in cancer treatment, and Rozlytrek allows us to treat tumors with specific genetic factors," said Levi Garraway, head of global product development at Roche,
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Rozlytrek was first approved in Japan last year for the treatment of late-stage recurrent solid tumors with NTRK gene fusion.
Rozlytrek has also been approved in the United States, Australia, Canada, Hong Kong, Israel, New Zealand, South Korea and Taiwan.
According to Roche, the European approval is based on a comprehensive analysis, including data from the STARTRK-2 Study II, the I-STARTRK-1 Study, and the I/II START-NG Paediatric Patient Study.
results showed that Rozlytrek narrowed the tumor in more than half of the patients with NTRK fusion-positive, locally advanced or metastatic solid tumors, with an overall remission rate (ORR) of 63.5 percent, and objective remission was observed in 14 tumor types.
at the same time, in the ROS1-positive late NSCLC, 73.4% of patients had reduced tumor volume.
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