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Nonrulemaking
FDA
Open for Comments
FDA-2026-P-6738
Request that FDA order sponsors of immunotherapies for NSCLC to revise their respective Prescribing Information to reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first line option, relying on its statutory authority under section 505(o)(4) of the FDC Act.
Documents
43
Comments
2
Description
Open
Key Dates
Comment Period OpensJun 16, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Comment Statistics
Total Comments
2
Keywords
CDER
Citizen Petition
Ochsner MD Anderson Cancer Center
Request that FDA order sponsors of
immunotherapies for NSCLC to revise their
respective Prescribing Information to reflect
that patients with ROS1 and RET rearrangements
should use targeted therapies as their
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