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.
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.
Other Name: JNJ-42756493
Inclusion Criteria: - Participant has a documented fibroblast growth factor receptor (FGFR) alteration - Participant does not have co-morbidities that would alter risk-benefit of providing erdafitinib (determined by treating physician's assessment) - Life expectancy is greater than (>) 3 months (determined by treating physician's assessment) - Participant has exhausted treatment options for their disease (review of prior treatments) - Participant is not eligible for other erdafitinib clinical trials including but not limited to BLC3001/NCT03390504 and BLC2002/NCT03473743
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC