J&J Files for US Approval of Cancer Drug Erdafitinib


On September 18, Johnson & Johnson (JNJ) announced that it had submitted a new drug application to the FDA for its investigational drug, erdafitinib, for the treatment of locally advanced or metastatic UC (urothelial cancer) in patients with certain FGFR (fibroblast growth factor receptor) genetic alterations. The application is based on the findings of BLC2001, a Phase 2 study. Erdafitinib, one of the company’s key pipeline products, is expected to drive growth. The diagram below shows some of J&J’s recent pharmaceutical launches and filings expected over the next few years.

J&J Files for US Approval of Cancer Drug Erdafitinib

In March, J&J received breakthrough therapy designation for erdafitinib from the FDA. Breakthrough therapy designation enables a faster review of treatments that show substantially better results than available therapy options for life-threatening conditions.

Market opportunity for erdafitinib

According to Johnson & Johnson, UC, a type of bladder cancer, is estimated to be the sixth most common type of cancer in the United States. Bladder cancer is expected to be diagnosed in ~81,190 people this year, and ~17,240 people could die due to bladder cancer. As UC patients have poor treatment outcomes with the currently available therapy options, there is a good market opportunity for erdafitinib.

Existing therapy options for the treatment of UC include Merck’s (MRK) Keytruda and Pfizer’s (PFE) Bavencio. Companies with oral FGFR inhibitor drugs undergoing study include Incyte (INCY) and AstraZeneca (AZN).

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