Johnson & Johnson Comes Out Of Gate With First Approval For Targeted Bladder Cancer Therapy
Summary
- 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.
- Looking for a portfolio of ideas like this one? Members of Biotech Analysis Central get exclusive access to our model portfolio. Start your free trial today »
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 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.
Personalized Treatment Approach
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.
Conclusion
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.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers deep dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
This article was written by
I am the Founder of Biotech Analysis Central, A subscription service on Seeking Alpha's Marketplace. If you want to learn more about biotech investing or you want to check out my biotech analysis you can do so with a free 2-week trial to my service. Just hit the "Learn More" button on the bottom of the Marketplace Research Tab. I have a Bachelors of Applied Science Degree In Technology Management, Industrial and Business Services Management from St. Petersburg College Florida. I have been investing in biotech stocks for many years, and I prefer to invest as a long term investor. With that In mind I seek stocks that have long term value! I primarily Like to Invest In biotechnology stocks and I accept the risks. I Write for the Healthcare Sector and Stock market in general. I contribute to Seeking Alpha.
You can follow me on stocktwits.com under the name BiopharmaPro where I currently have (62.5K) followers. Join me in my quest to find the best biotechnology stocks that deliver results to help patients with new treatment options.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.