News Related to ROS1-Positive Non-Small Cell Lung Cancer

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FDA Reviews Updated Taletrectinib Data in Advanced ROS1-Positive NSCLC

May 11, 2026

The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.

Nuvalent Outlines FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans

Feb 15, 2026

Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 2026.