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Roche: FDA-approved Rozlytrek

Roche reports that the US Food and Drug Administration (FDA) has approved its Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive non-small cell lung cancer.

The United States Health Authority also granted the drug accelerated approval for the treatment of adults and children 12 years of age and older with certain NTRK fusion tumors without a known mutation of acquired resistance.

The Swiss Health Group points out that these approvals are based on the results of the integrated analysis of the Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001, as well as the STARTRK-NG Phase I / II studies.

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