Therapy Areas: Oncology
Janssen submits erdafitinib's NDA with the US FDA for the treatment of metastatic urothelial cancer
19 September 2018 -

Janssen Pharmaceutical Companies said on Tuesday that it has successfully filed its New Drug Application (NDA) for erdafitinib with the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic urothelial cancer (UC), which most occurs frequently in the bladder.

The company is seeking US FDA approval for erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumours have progressed after prior chemotherapy.

According to the company, erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received the US FDA's Breakthrough Therapy Designation in March 2018. FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in tumour types and lead to increased tumour cell growth and survival.

In addition, the NDA submission is based on data from the company's BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumours have certain FGFR alterations. The primary endpoint was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors Version 1.1 criteria.

Concurrently, the study results from the company's Phase 2 clinical trial were presented at the American Society of Clinical Oncology 2018 Annual Meeting in Chicago.

Janssen Pharmaceutical Companies is part of Johnson & Johnson (NYSE:J&J), a healthcare company.

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