New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC
U.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025
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