JNJ 42756493 filed with the FDA for metastatic urothelial cancer.- Janssen R&D.
Janssen Pharmaceutical announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of JNJ 42756493 (erdafitinib) for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.
The NDA submission is based on data from the BLC2001 (NCT02365597) Phase II clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations. The primary endpoint of this study was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1* criteria. The study results were recently presented at the American Society of Clinical Oncology (ASCO) 2018.
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