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.
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.