Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 8

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 8
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 jurisdiction where we execute and locate a clinical trial. Although the FDA,
EMA and any comparable foreign regulatory authority may accept data from clinical trials conducted
outside the relevant jurisdiction, acceptance of these data is subject to certain conditions. Local regulatory authorities can request specific changes to the clinical trial protocol or specific safety measures that differ from the positions taken in other jurisdictions. For example, the FDA requires that the clinical trial must be well-designed and conducted and performed by qualified investigators in accordance with ethical principles such as institutional review board or ethics committee approval and informed consent, an adequately representation of the U.S. population in the trial population and data that is applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. Further, the FDA may consider an on-site inspection to be necessary in which case they must be able to validate the data through such an inspection or other appropriate means. In addition, while these clinical trials are subject to the applicable local laws, acceptance of the data by the FDA will depend upon its determination that the trials were conducted consistent with all applicable U.S. laws and regulations. Similarly, any data submitted to foreign regulatory authorities may not adhere to their standards and requirements for clinical trials and data from trials conducted outside of such jurisdiction may not be accepted.
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Moreover, in November 2023, the FDA announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed autologous chimeric antigen receptor, or CAR, -T cell immunotherapies following reports of T-cell lymphoma in patients receiving these therapies. In January 2024, the FDA determined that new safety information related to T-cell malignancies should be included in the labeling with boxed warning language on these malignancies for all BCMA- and CD-19-directed genetically modified autologous T-cell immunotherapies. Additionally, EMA’s safety committee (the Pharmacovigilance Risk Assessment Committee, or PRAC) started a signal procedure to review data on secondary malignancies related to T-cells, including T-cell lymphoma and leukemia, for the six approved CAR-

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T cell medicines and adopted a set of recommendations including an update of the product information and related safety documentation at the June 2024 PRAC meeting. These conclusions and recommendations may also lead to additional scrutiny and safety follow-up measures for CAR-T cell products in development in the broader CAR-T class, which may differ between therapeutic areas or patient populations, for example, in