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.
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Drug Name
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BALVERSA (erdafitinib)
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Molecule type
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Small molecule
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Developer
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Johnson & Johnson
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Indication
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Urothelial Carcinoma
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Mechanism of action
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Fibroblast growth factor receptor antagonists
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Route of administration
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Oral
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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
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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.
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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.
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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.
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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.
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In August 2023, Janssen Pharmaceutical Companies of Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the FDA requesting full approval for BALVERSA.
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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.
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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.
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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
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1
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Report Introduction
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2
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BALVERSA: Johnson & Johnson
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2.1
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Product Overview
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2.2
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Other Development Activities
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2.3
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Clinical Development
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2.4
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Clinical Trials Information
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2.5
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Safety and Efficacy
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2.6
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Product Profile
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2.7
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Market Assessment
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2.7.1
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The 7MM Analysis
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2.7.1.1
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Cost Assumptions and Rebate
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2.7.1.2
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Pricing Trends
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2.7.1.3
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Analogue Assessment
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2.7.1.4
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Launch Year and Therapy Uptake
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2.7.2
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The United States Market Analysis
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2.7.3
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EU4 and the United Kingdom Market Analysis
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2.7.3.1
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Germany
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2.7.3.2
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France
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2.7.3.3
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Italy
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2.7.3.4
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Spain
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2.7.3.5
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UK
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2.7.4
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Japan Market Analysis
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2.8
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Market Drivers
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2.9
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Market Barriers
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2.10
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SWOT Analysis
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3
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Key Cross of Marketed Competitors of BALVERSA
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4
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Key Cross of Emerging Competitors of BALVERSA
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