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.
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 a complete response (CR) and 29.99% achieving a partial response. Even better, those who responded on BALVERSA did not respond when given anti PD-L1/PD-1 treatment either.
Along with the FDA approval of BALVERSA for metastatic bladder cancer patients with FGFR mutations, a companion diagnostic test was also approved. The FDA also had approved therascreen FGFR RGQ RT-PCR Kit, which was developed by QIAGEN Manchester, Ltd. to help diagnosis. The main point to consider here is that besides cancer drugs eventually being combined to treat cancer, another avenue should be explored. This involves the use of developing drugs as personalized approaches to medicine. For instance, the metastatic patients that took BALVERSA had the FGFR3 or FGFR2 genetic alteration. The medicine was developed to target the specific cause of the cancer for these patients. What does that do for the patient? It improves target specificity, which in theory should increase efficacy of the drug. Other types of cancer drugs are developed to treat a more broad population of the disease. The targeted approach is a more superior way to treat these patients with specific genetic alterations.
The FDA approval of BALVERSA for metastatic bladder cancer patients with FGFR genetic alterations is good news for these patients. That's because the drug is the first of its kind to be approved as a targeted therapy for metastatic bladder cancer with FGFR genetic alterations. That means not only was history made, but it offers these patients a new treatment option. There may have been several other drugs from Merck (MRK) with Keytruda and Roche (OTCQX:RHHBY) with Tecentriq, but nothing that offers such a personalized approach like BALVERSA. I think this will definitely help out Johnson & Johnson in the long run. Not like it is in trouble or anything, but this will definitely help with some additional sales in J&J's commercialized pipeline.
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