Exploration of Targeted Anti-tumor Therapy

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Table 2

From: FDA 2025 Cancer Drug Approvals: targeted therapy dominates

Table 2. Cancer drugs approved by the FDA in 2025 that utilized the clinical enrichment trial design. In addition to the generic names of the drugs, the table provides information on biomarkers, specific design characteristics, and available regulatory-approved CDx assays [5, 7].

Drug	CDx Biomarker	Trial Design	Approved CDx Assay
Avutometinib plus defactinib	KRAS	Single arm	Not available at the time of drug approval
Telisotuzumab vedotin	c-Met	Single arm	Ventana MET (SP44) RxDx Assay
Taletrectinib	ROS1	Single arm	Not available at the time of drug approval
Sunvozertinib	EGFR exon 20 insertion	Randomized open-label	Oncomine Dx Express Test
Dordaviprone	H3 K27M	Single arm	Not available at the time of drug approval
Zongertinib	HER2	Single arm	Oncomine Dx Target Test
Pembrolizumab & berahyaluronidase alfa	PD-L1 MSI-H dMMR TMB-H	See prescribing information [9]	PD-L1 IHC 22C3 FoundationOne CDx Ventana MMR RxDx Panel MI Cancer Seek
Imlunestrant	ESR1	Randomized open-label	Guardant360 CDx
Ziftomenib	NPM1	Single arm	Not available at the time of drug approval
Sevabertinib	HER2	Single arm	Oncomine Dx Target Test

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Declarations

Author contributions

JTJ: Conceptualization, Formal analysis, Writing—original draft, Writing—review & editing. The author read and approved the submitted version.

Conflicts of interest

JT Jørgensen has served as a consultant and advisor for AstraZeneca and Visiopharm, as well as received royalties from Elsevier.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

The following data sources were used: Mullard A. 2025 FDA approvals. Nat Rev Drug Discov. 2026;25:81–7. [DOI: 10.1038/d41573-026-00001-z]; Drugs@FDA: FDA-approved drugs. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/; Search Orphan Drug Designations and Approvals. Available from: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/; List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available from: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

Funding

Not applicable.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

References

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Mullard A. 2025 FDA approvals. Nat Rev Drug Discov. 2026;25:81–7. [DOI]

Drugs@FDA: FDA-approved drugs [Internet]. FDA; [cited 2026 Jan 23]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/

Search Orphan Drug Designations and Approvals [Internet]. FDA; [cited 2026 Jan 23]. Available from: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/

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