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J&J Files NDA for Erdafitinib in Urothelial Cancer Indication

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J&J Files NDA for Erdafitinib in Urothelial Cancer Indication

Johnson & Johnson (JNJ) submits regulatory application to the FDA seeking approval of pan-FGFR inhibitor, erdafitinib, for the treatment of metastatic urothelial cancer, a type of bladder cancer.

Johnson & Johnson JNJ announced that its subsidiary Janssen has filed a new drug application (“NDA”) seeking approval of its pan-FGFR inhibitor, erdafitinib, as a treatment for metastatic urothelial cancer (“UC”), a type of bladder cancer. The NDA seeks approval of the candidate for treating UC in patients with certain fibroblast growth factor receptor (“FGFR”) genetic alterations and whose tumors have progressed after prior chemotherapy.

The candidate enjoys Breakthrough Therapy designation, which is expected to translate to a speedy review of the regulatory application once accepted by the FDA.

J&J stock has declined 0.6% this year so far against 6.2% increase recorded by the industry.

The NDA includes data from a phase II study, evaluating erdafitinib in advanced urothelial cancer indication and showed an overall response rate of 42%. The study data were presented at the annual meeting of ASCO 2018 and selected as "Best of ASCO".

Per the press release, urothelial cancer is the sixth most common cancer type affecting people in the United States. Bladder cancer is estimated to be diagnosed in 81,190 new patients in 2018 and will cause death of 17,240 patients. Moreover this patient population has witnessed poor outcomes when treated with available therapies. In fact, only 5% of the patients diagnosed with Stage IV metastatic bladder cancer survive beyond five years of treatment. Also, patients with FGFR mutation have poor prognosis and significant unmet need.

Pfizer’s PFE and Merck’s MRK immuno-oncology therapies, Bavencio and Keytruda, respectively are already approved for the UC. Eli Lilly LLY is developing its cancer drug, Cyramza for UC in a late-stage study. Nektar Therapeutics and Bristol-Myers are developing a combination of immuno-oncology products, NKTR-214 and Opdivo, respectively in an early stage study.  Several other pharma companies have approved drugs or developing candidates in their portfolio for treating UC.

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J&J currently carries 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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