An expanded access record providing Erdafitinib in Advanced Cancers and FGFR Genetic Alterations, sponsored by Janssen Scientific Affairs, LLC. Approved for marketing. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Janssen Scientific Affairs, LLC · Expanded access
The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration [FDA] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.
Inclusion Criteria:
Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.
Also known as: JNJ-42756493
No study locations are listed for this record.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Janssen Scientific Affairs, LLC