Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small cell lung cancer (NSCLC). Augtyro is administered as an oral therapy, 160 mg orally once daily for 14 days, then increased to 160 mg twice daily. BMS’ repotrectinib (Augtyro) could challenge Pfizer’s Xalkori and Roche’s Rozlytrek, other approved medications for ROS1-positive NSCLC.
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