Roche drug is third to win biomarker-driven cancer approval from FDA
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
Japanese regulators say ‘engage’ on Roche’s Trk inhibitor
The FDA is expected to reach a decision by August on the drug, Rozlytrek, a tumor-agnostic cancer drug and potential competitor to Bayer's Vitrakvi.
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