R&D

J&J nabs accelerated FDA OK for one of their top late-stage drugs

Score one new potential blockbuster OK for J&J.

The FDA offered a quick stamp of approval for their solid tumor drug erdafitinib Friday afternoon, allowing the pharma giant to put a checkmark by one of their top pipeline projects. Execs highlighted this drug close to 2 years ago as one of the top 11 therapies they were steering through late-stage trials. And it’s a key part of an R&D plan aimed at reviving sales growth.

The FDA blessed this therapy with its breakthrough designation a little more than a year ago, helping to speed it through the review process.

The drug — an FGFR inhibitor for a set of genetically mutated cases of bladder cancer — will now head to the market to be sold as Balversa. We don’t have the cost yet, but I’ve queried the company. 

Richard Pazdur

“Today’s approval represents the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “FGFRs regulate important biological processes including cell growth and division during development and tissue repair. This drug works by targeting genetic alterations in FGFRs.”

The FDA summarized the data like this:

The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately five-and-a-half months. About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to Balversa were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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