BALVERSA Adoption on the Rise: Meeting Unmet Needs in Advanced Urothelial Cancer | DelveInsight

BALVERSA (erdafitinib) has strong market potential in the FGFR-altered urothelial carcinoma space, particularly as a targeted therapy for patients with FGFR2/3 mutations. With the growing emphasis on precision oncology, its uptake is expected to increase, especially if expanded to earlier treatment lines or additional FGFR-driven tumors.

New York, USA, March 04, 2025 (GLOBE NEWSWIRE) — BALVERSA Adoption on the Rise: Meeting Unmet Needs in Advanced Urothelial Cancer | DelveInsight

BALVERSA (erdafitinib) has strong market potential in the FGFR-altered urothelial carcinoma space, particularly as a targeted therapy for patients with FGFR2/3 mutations. With the growing emphasis on precision oncology, its uptake is expected to increase, especially if expanded to earlier treatment lines or additional FGFR-driven tumors.

DelveInsight’s “BALVERSA Market Size, Forecast, and Market Insight Report” highlights the details around BALVERSA, a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BALVERSA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Johnson & Johnson’s BALVERSA (erdafitinib) Overview

BALVERSA (erdafitinib) is a broad-spectrum fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor approved for treating adult patients with unresectable or metastatic urothelial carcinoma that carries specific FGFR3 genetic alterations. It is indicated for individuals who have previously undergone at least one line of therapy, including a PD-1 or PD-L1 inhibitor, in the unresectable or metastatic setting.  

The drug is also being investigated in the Phase 1 BLC1003 (NCT05316155) trial for patients with non-muscle invasive or muscle-invasive bladder cancer with selected FGFR alterations, using an intravesical targeted releasing system (TAR-210). Additionally, the Phase 3 MoonRISe-1 (BLC3004, NCT06319820) study is assessing TAR-210 compared to single-agent intravesical chemotherapy in patients with intermediate-risk non-muscle invasive bladder cancer.  

Beyond its approval by the European Commission (EC), Johnson & Johnson secured U.S. FDA approval for erdafitinib in January 2024 for adult patients with locally advanced or metastatic UC harboring susceptible FGFR3 genetic alterations. This approval was based on findings from Cohort 1 of the Phase 3 THOR study.  

Erdafitinib originated from a collaboration between Janssen Pharmaceutica NV and Astex Therapeutics Limited, which established an exclusive global licensing and development agreement in 2008.

Learn more about BALVERSA projected market size for urothelial carcinoma @ BALVERSA Market Potential 

Urothelial carcinoma is the most prevalent malignancy of the urinary system, originating from urothelial cells and typically emerging in individuals aged 50 and above. It is more common in males, with an incidence rate two to three times higher than in females. According to DelveInsight’s analysis, there were approximately 41 million incident cases of urothelial carcinoma across the 7MM in 2023.  

The primary treatment approach involves chemotherapy, such as cisplatin-based regimens. Immunotherapy, including agents like atezolizumab and pembrolizumab, serves as a secondary treatment option for patients who do not respond to initial systemic therapy. Surgical procedures like nephroureterectomy are also performed in certain cases. Several approved drugs for urothelial carcinoma treatment include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), BAVENCIO (avelumab), and others.  

The urothelial carcinoma treatment landscape is expected to undergo significant advancements from USD 900 million in 2023 at a significant CAGR by 2034, driven by the introduction of novel therapies currently in clinical development. However, factors such as treatment challenges in elderly patients and reliance on blood transfusions may hinder market growth.

Dive deep into an in-depth assessment of the Urothelial Carcinoma Market

Emerging Competitors of BALVERSA

The pipeline of urothelial carcinoma is very robust, emerging therapies such as IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others are being developed for safe and efficacious treatments.

The anticipated launch of these therapies will not only boost the urothelial carcinoma treatment space but also pose a threat to Johnson & Johnson’s BALVERSA.

To know more about the number of competing drugs in development, visit @ BALVERSA Market Positioning Compared to Other Drugs

Key Milestones of BALVERSA 

• In August 2024, Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, announced that the European Commission (EC) approved BALVERSA (erdafitinib) as a once-daily oral monotherapy for adults with unresectable or metastatic urothelial carcinoma that carries specific FGFR3 genetic alterations. This approval applies to patients who have previously undergone at least one treatment regimen that included a PD-1 or PD-L1 inhibitor in the unresectable or metastatic setting.
• In June 2024, Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization for BALVERSA. This once-daily oral monotherapy is intended for adults with unresectable or metastatic urothelial carcinoma who have FGFR3 genetic alterations and have previously undergone at least one line of treatment with a PD-1 or PD-L1 inhibitor in the same setting. Erdafitinib is the first targeted therapy to receive a positive CHMP recommendation for this patient group.
• In January 2024, Johnson & Johnson announced that the FDA approved a supplemental New Drug Application (sNDA) for BALVERSA to treat adult patients with locally advanced or metastatic urothelial carcinoma harboring specific FGFR3 genetic alterations, whose disease has worsened after at least one prior systemic therapy.
• In October 2023, Janssen Pharmaceutical Companies of Johnson & Johnson released findings from the Phase 2 THOR-2 study, a randomized, open-label trial comparing BALVERSA to investigator-selected intravesical chemotherapy in patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have specific FGFR alterations and experienced recurrence following Bacillus Calmette-Guérin (BCG) therapy.
• In August 2023, Janssen Pharmaceutical Companies of Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the FDA requesting full approval for BALVERSA.
• In June 2023, Johnson & Johnson released interim findings from Cohort 1 of the Phase 3 THOR study, comparing BALVERSA to chemotherapy in patients with metastatic or inoperable urothelial carcinoma who have specific FGFR gene alterations and have previously been treated with an anti-PD-[L]1 therapy.
• In June 2022, Johnson & Johnson released initial findings from the pivotal Phase 2 RAGNAR study, which is assessing the investigational use of BALVERSA, an FGFR kinase inhibitor, in patients with advanced solid tumors exhibiting specific FGFR alterations.
• In April 2019, Janssen Pharmaceutical announced that the FDA had granted accelerated approval to BALVERSA for the treatment of adults with locally advanced or metastatic urothelial carcinoma that carries specific FGFR3 or FGFR2 genetic alterations.

Discover how BALVERSA is shaping the urothelial carcinoma treatment landscape @ BALVERSA Urothelial Carcinoma

BALVERSA Market Dynamics

As the first FDA-approved targeted therapy for FGFR-altered bladder cancer, BALVERSA has carved out a niche within the broader urothelial carcinoma treatment landscape, offering a precision medicine approach where traditional chemotherapy options have shown limited efficacy.

The market dynamics of BALVERSA are shaped by several key factors, including increasing awareness and adoption of biomarker-driven oncology treatments. As genetic testing becomes more widespread, more patients with FGFR alterations are being identified, thereby expanding the potential market for BALVERSA. However, its market penetration is influenced by competition from immune checkpoint inhibitors such as pembrolizumab and avelumab, as well as other emerging targeted therapies and antibody-drug conjugates (ADCs) targeting urothelial carcinoma. The high cost of FGFR testing and BALVERSA’s premium pricing also pose barriers to widespread adoption, particularly in regions with limited healthcare reimbursement support.

Another critical factor in BALVERSA’s market trajectory is its potential for label expansion. Ongoing clinical trials are investigating its efficacy in earlier lines of therapy and in combination with other agents, which could significantly enhance its market potential. If proven effective in broader patient populations, BALVERSA could gain a competitive edge over existing therapies. Additionally, the rise of novel FGFR inhibitors in clinical development, such as futibatinib and rogaratinib, presents both a challenge and an opportunity, as they could either complement or compete with BALVERSA, depending on differentiation in safety and efficacy profiles.

Overall, BALVERSA’s market dynamics are shaped by the growing emphasis on precision oncology, competition from alternative therapies, regulatory developments, and ongoing clinical research. While its current positioning is strong within the FGFR-altered urothelial carcinoma segment, its long-term success will depend on continued clinical advancements, pricing strategies, and the evolving competitive landscape of targeted cancer therapies.

Dive deeper to get more insight into BALVERSA’s strengths & weaknesses relative to competitors @ BALVERSA Market Drug Report

Table of Contents

Related Reports

Urothelial Carcinoma Market

Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others.

Urothelial Carcinoma Pipeline

Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others.

Metastatic Urothelial Carcinoma Market

Metastatic Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic urothelial carcinoma companies including Novaliq GmbH, Kowa, D. Western Therapeutics Institute, Sun Pharma Advanced Research Company, among others.

Metastatic Urothelial Carcinoma Pipeline

Metastatic Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic urothelial carcinoma companies, including Ectin Research AG, Eli Lilly and Company, Astellas Pharma Inc, Seagen Inc., Shanghai Miracogen Inc., Advaxis, Inc., 4D pharma plc, Taiho Oncology, Shanghai Miracogen Inc., Exelixis, AstraZeneca, Incyte Corporation, IO Biotech, Jazz Pharmaceuticals, Ectin Research AB, Inovio Pharmaceuticals, Janssen Research & Development, LLC, Sumitomo Pharma Oncology, Bayer, Nurix Therapeutics, Ikena Oncology, XNK Therapeutics AB, Nektar Therapeutics, Tyra Biosciences, Inc., ALX Oncology, Scholar Rock, Inc., Jounce Therapeutics, Inc., among others.

Bladder Cancer Market

Bladder Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies, including Pfizer, Celgene Corporation, Eli Lilly, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, Hoffmann-La Roche, Novartis International, Johnson & Johnson, Merck & Co Inc., Vault Pharma Inc., Vyriad Inc., among others.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

CONTACT: Contact Us

Shruti Thakur 

info@delveinsight.com 

+14699457679 

www.delveinsight.com