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

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

Johnson&Johnson (J&J) Signs a Research Collaboration with Apple for Atrial Fibrillation (AFib)

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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