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J&J's (JNJ) Erdafitinib Gets Breakthrough Therapy Status

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Johnson & Johnson JNJ announced that the FDA has granted breakthrough therapy designation to its late-stage pipeline candidate, erdafitinib for the treatment of urothelial cancer, a type of bladder cancer.

The designation from the FDA is intended to expedite the development and review of drugs with early evidence of substantial potential clinical benefit to patients, or benefit patients without current treatment options.

The designation for erdafitinib was primarily based on efficacy findings from a phase II study, evaluating it in advanced urothelial cancer indication and showed an overall response rate of 42%.

J&J stock declined 4.2% this year so far, which compares unfavorably with a gain of 0.9% recorded by the industry.

Urothelial cancer, which starts in the urothelial cells that line the inside of the bladder, is usually characterized by serious outcomes due to the often rapid progression of the tumor and the lack of efficacious treatments. It is the sixth most common form of cancer in the United States. It is estimated that more than 81,000 new cases of bladder cancer will be diagnosed this year, per a J&J press release.

J&J has a robust pipeline. The company expects to launch or file for approval more than 10 new blockbuster products by 2021. The company is targeting more than 50 line extensions of existing and new drugs as well. This should help lessen the impact of genericization of key products in the pharma portfolio.

Key late-stage candidates in the company’s pipeline include esketamine (treatment-resistant depression), niraparib (prostate cancer), and imetelstat (myelofibrosis) among others. While a regulatory filing in the United States for esketamine is expected in 2018 that for niraparibis expected next year. Please note that imetelstat is being developed in partnership with Geron Corporation GERN.

An important new drug, Guselkumab/Tremfya was approved last year wasfor plaque psoriasis. Also,the first dual treatment for HIV, Juluca (dolutegravir + rilpivirine) received approval in the United States in November last year while the candidate is under review in the EU. Juluca has been developed by J&J in partnership with ViiV Healthcare, an HIV company majorly owned by Glaxo GSK and Pfizer PFE.

Meanwhile, Symtuza, a darunavir-based once-daily single-tablet regimen for the treatment of HIV is under review in the United States. Symtuza was approved in the EU in September last year.

J&J 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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