Johnson & Johnson Comes Out Of Gate With First Approval For Targeted Bladder Cancer Therapy

Apr. 29, 2019 8:07 PM ETJohnson & Johnson (JNJ)8 Comments


  • Johnson & Johnson received FDA approval for BALVERSA specifically tailored for patients with metastatic bladder cancer who have specific genetic alterations.
  • FDA approval was based on a single-arm phase 2 trial in which treatment with BALVERSA resulted with a 32% overall response rate.
  • A companion diagnostic, known as therascreen FGFR RGQ RT-PCR Kit, was also approved in tandem with BALVERSA.
  • The ability for J&J to get BALVERSA approved for patients with metastatic bladder cancer with specific FGFR genetic alterations means a more targeted treatment approach with less off-target effects.
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Johnson & Johnson (NYSE:JNJ) has made substantial groundbreaking news, because it was the first to receive FDA approval for metastatic bladder cancer that deals with specific FGFR genetic alterations. This is good news for both JNJ and for patients who desperately needed a treatment for their cancer. The downside is that it was only for a specific sub-population, but I believe that, eventually, the product can be tested in other types of cancer. Meaning, to possibly be tested in the entire metastatic bladder cancer population and other cancers that have the FGFR genetic alterations.

FDA Approval

The FDA approved BALVERSA (erdafitinib) specifically to treat patients with metastatic bladder cancer who either had the FGFR3 or FGFR2 genetic alteration. Why is this approval so special for these metastatic bladder cancer patients? Quite simply, to this day, treatment options are limited. Consider that platinum-based chemotherapy is still the first-line treatment of choice for these patients. There weren't many options, but now with BALVERSA, these patients have a solid option. I believe this approval is not only solid for that particular reason. The other reason why I think it's a good approval is because it offers a more personalized treatment approach. The ability for the drug to target those patients with a specific genetic alteration, in my opinion, leads to a more pronounced drug effect. This, as opposed to targeting a broad metastatic bladder cancer population. Here is where it gets real interesting, because FDA approval was based on the single-arm phase 2 BLC2001 trial. There were 87 patients recruited into the study with an FGFR genetic alteration. In addition, it's important to note is that these patients had progressed after having received at least one prior chemotherapy treatment. It was shown in the study that a 32% overall response rate (ORR) was obtained. This is broken down to 2.3% achieving

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