Johnson & Johnson’s Balversa (erdafitinib) Receives FDA’s Approval for Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alteration

Shots:

• The approval is based on P-II (BLC2001, NCT02365597) study results assessing 87 patients with disease that had progressed on or after at least one prior chemotherapy and that had at least one of FGFR3 gene mutations or FGFR gene fusion
• P-II study results: ORR 32.2%, mDoR 5.4 mos., Presented at ASCO’18
• BALVERSA (erdafitinib) is a qd , oral FGFR kinase inhibitor. The US FDA has also approved a CDx for Balversa, the QIAGEN therascreen FGFR RGQ Reverse-transcription (RT)-polymerase chain reaction (PCR) Kit novel PCR based diagnostic approved to detect FGFR alterations 

Click here to read full press release/ article | Ref: Johnson & Johnson | Image: Bioworld