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.
Scancell initiates SCOPE trial's iSCIB1+ cohort
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval
Poseida Therapeutics names new chief medical officer
Biocytogen and ABL Bio collaborate on development of new bispecific antibody-drug conjugates
BioVaxys Technology announces non-brokered private placement
Senhwa Biosciences doses first subject in phase II study of Silmitasertib
Antennova completes first dosing cohort in Phase one study of ATN-031
M8 Pharmaceuticals collaborates with SERB Pharmaceuticals
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib
Phanes Therapeutics receives FDA Fast Track designation for PT886