J&J's Erdafitinib Gets FDA Approval for Urothelial Cancer

Johnson & Johnson JNJ announced that the FDA has granted accelerated approval to erdafitinib for the treatment of locally advanced/metastatic urothelial cancer, a type of bladder cancer, in patients with certain FGFR genetic alterations. Erdafitinib, the first FGFR kinase inhibitor to be approved by the FDA, will be marketed by the trade name of Balversa

The new drug application for Balversa was filed with the FDA in September last year and was granted priority review. The NDA was based on data from a phase II study. Data from the study showed that treatment with erdafitinib led to durable responses in patients with metastatic urothelial cancer with genetic alteration — a patient population that witnessed poor outcomes when treated with available therapies. Urothelial cancer is the sixth most common cancer type affecting people in the United States and is the most common type of bladder cancer.

Meanwhile, the FDA also granted a simultaneous approval to a companion diagnostic for use with Balversa. The purpose of the test is to identify patients with FGFR genetic alterations and therefore most likely to benefit from Balversa.

J&J’s stock has risen 5.4% this year so far against a decline of 0.1% recorded by the industry.


Pfizer’s PFE and Merck’s MRK immuno-oncology therapies, Bavencio and Keytruda, respectively are also approved to treat urothelial cancer. Eli Lilly LLY is developing its cancer drug, Cyramza for urothelial cancer in a late-stage study. Several other pharma companies have approved drugs or developing candidates in their portfolio for treating urothelial cancer.

This is J&J’s second FDA approval for a new drug in less than two months. In early March, J&J gained FDA approval for another key pipeline candidate - its nasal spray, Spravato (esketamine) for treatment-resistant depression (TRD) in adults. With the approval, Spravato, which is thought to work differently from currently approved therapies, will be the first new medicine in 30 years to treat depression, a difficult-to-treat mental disease. It has been seen that while most antidepressants take a couple of weeks or months to show effects, Spravato works in hours.

J&J believes that both Spravato and erdafitinib have the potential for more than $1 billion of peak revenues.

J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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