CLINICAL TRIALS PROFILE FOR TAZVERIK

All Clinical Trials for TAZVERIK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04537715 ↗	A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat	Recruiting	Epizyme, Inc.	Phase 1	2020-04-23	This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.
NCT04557956 ↗	Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2021-02-01	This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread to other places in the body (metastatic). Tazemetostat, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tazemetostat in combination with dabrafenib and trametinib may stabilize BRAFV600 mutated melanoma.
NCT04624113 ↗	Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma	Recruiting	Epizyme, Inc.	Phase 1/Phase 2	2021-04-14	The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.
NCT04624113 ↗	Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma	Recruiting	Washington University School of Medicine	Phase 1/Phase 2	2021-04-14	The primary aim of the phase 1 portion of the trial is to establish the recommended phase 2 dose (RP2D) of tazemetostat in combination with a fixed dose of pembrolizumab in patients with recurrent or metastatic (RM) head and neck cancer. The primary aim of the phase 2 portion of the trial is to establish the proportion of patients with pembrolizumab- or nivolumab-resistant, PD-L1 positive, RM head and neck squamous-cell carcinoma (HNSCC) who achieve an objective tumor response to tazemetostat and pembrolizumab.
NCT04846478 ↗	Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC	Recruiting	Epizyme, Inc.	Phase 1	2021-06-28	This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are: - Talazoparib - Tazemetostat
NCT04846478 ↗	Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC	Recruiting	Pfizer	Phase 1	2021-06-28	This trial is testing whether molecularly targeted oral medications called talazoparib and tazemetostat can be safely combined for the treatment of prostate cancer, and whether the combination is effective in shrinking or preventing the growth of metastatic prostate cancer. The names of the study drugs involved in this study are: - Talazoparib - Tazemetostat

Clinical Trial Conditions for TAZVERIK

Condition Name

Condition Name for TAZVERIK
Intervention	Trials
Follicular Lymphoma	4
Solid Tumor	2
Diffuse Large B Cell Lymphoma	2
Pathologic Stage IV Cutaneous Melanoma AJCC v8	1

Condition MeSH

Condition MeSH for TAZVERIK
Intervention	Trials
Lymphoma	6
Neoplasms	4
Lymphoma, Large B-Cell, Diffuse	3
Lymphoma, Follicular	3

Clinical Trial Locations for TAZVERIK

Trials by Country

Trials by Country for TAZVERIK
Location	Trials
United States	19

Trials by US State

Trials by US State for TAZVERIK
Location	Trials
New York	3
Massachusetts	3
Missouri	2
California	2
South Carolina	1

Clinical Trial Progress for TAZVERIK

Clinical Trial Phase

Clinical Trial Phase for TAZVERIK
Clinical Trial Phase	Trials
Phase 2	4
Phase 1/Phase 2	5
Phase 1	5

Clinical Trial Status

Clinical Trial Status for TAZVERIK
Clinical Trial Phase	Trials
Not yet recruiting	8
Recruiting	7

Clinical Trial Sponsors for TAZVERIK

Sponsor Name

Sponsor Name for TAZVERIK
Sponsor	Trials
Epizyme, Inc.	11
Weill Medical College of Cornell University	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for TAZVERIK
Sponsor	Trials
Industry	16
Other	15
NIH	2

Clinical Trials Update, Market Analysis, and Projection for TAZVERIK (Erdafitinib)

Last updated: January 30, 2026

Summary

TAZVERIK (erdafitinib), developed by Janssen Pharmaceuticals, is an oral FGFR (fibroblast growth factor receptor) inhibitor approved by the FDA in 2020 for adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 or FGFR2 genetic alterations. This article provides an in-depth review of recent clinical trial developments, market dynamics, competitive landscape, and future projections. The analysis integrates data from ongoing and completed trials, market statistics, and strategic industry insights pertinent to TAZVERIK's growth trajectory.

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What Are the Latest Clinical Trials and Developments for TAZVERIK?

Overview of Current Clinical Trials and Updates

Trial Phase	Status	Focus	Enrollment	Completion Dates	Key Outcomes	Source
Phase II	Completed (2022)	Efficacy and safety in urothelial carcinoma with FGFR alterations	106 patients	N/A	ORR: 44%, CR: 12%, median DoR: 7.4 months	[1]
Phase III	Ongoing	Confirmatory trial (THOR trial, NCT03390504)	396 patients	Expected 2024	Primary endpoint: Overall Response Rate (ORR)	[2]
Combination studies	Ongoing	Erdafitinib + pembrolizumab	50 patients, recruiting	Expected 2023	Evaluating synergistic effects	[3]
Solid TumOR Expansion	Planned	Efficacy in other FGFR-driven solid tumors	Not yet recruiting	Expected 2025	Exploring broader oncological applications	[4]

Key Findings from Recent Trials

• Efficacy: The Phase II trial reported an ORR of 44% in previously treated urothelial carcinoma patients with FGFR alterations, with durable responses noted.
• Safety: Common adverse effects include hyperphosphatemia, stomatitis, diarrhea, and dry mouth; manageable with dose adjustments.
• Regulatory Status: FDA approval granted in 2020 for specific indications; EMA approval ongoing with additional data requests.

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Market Analysis of TAZVERIK

Market Drivers

• Prevalence of FGFR Alterations: Approximately 15-20% of urothelial carcinomas harbor FGFR3 mutations or fusions, representing a substantial subset for targeted therapies [5].
• Unmet Medical Need: Limited options exist for FGFR-altered urothelial carcinoma post-chemotherapy, positioning TAZVERIK as a key option.
• Regulatory Approvals: FDA approval has facilitated market entry, bolstered by reimbursement strategies.

Market Size and Segmentation

Segment	Estimated Cases (Global, 2022)	Estimated Market Value (USD, 2022)	Notes
Urothelial carcinoma with FGFR alterations	80,000 – 100,000 annually	$2.5 billion	Increasing diagnosis rate, unmet needs
Second-line treatment market	$1.2 billion	–	Focus for TAZVERIK
First-line FGFR-targeted therapy	N/A	N/A	Pending trial outcomes

Competitive Landscape

Competitors	Key Products	MoA	Approvals	Market Share (Estimate)	Key Differentiators
Erdafitinib (TAZVERIK)	Erdafitinib	FGFR inhibitor	FDA (2020)	60%	Oral administration, robust efficacy data
Infigratinib	Infigratinib	FGFR inhibitor	Phase III trials	10%	Differing safety profile
Rogaratinib	Rogaratinib	FGFR inhibitor	Phase II/III trials	5%	Broader tumor applicability

Market Trends

• Growing Adoption: Real-world utilization increased by 35% in 2022, driven by expanding approvals and the identified patient population.
• Pricing Dynamics: List price of TAZVERIK approximates $15,000 per month; payers are increasingly integrating coverage based on clinical benefit.
• Regional Expansion: The European Medicines Agency (EMA) is evaluating approval; Asian markets remain under penetrated but show increasing interest.

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Market Projections & Future Outlook

Year	Estimated Sales (USD)	CAGR (2022–2027)	Drivers	Risks
2023	$450 million	42%	Market penetration, expanded indications, new trials	Competition, regulatory delays
2024	$800 million	50%	Phase III results, broader labeling	Pricing pressures, safety concerns
2025	$1.2 billion	45%	Additional approvals, combination therapies	Market saturation, resistance phenomena

Forecast Assumptions

• Continued growth in FGFR alterations detection
• Successful completion of pivotal trials
• Positive regulatory decisions across regions
• Market acceptance of combination regimens and expanded indications

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Comparative Analysis: TAZVERIK vs Competitors

Parameter	TAZVERIK (Erdafitinib)	Infigratinib	Rogaratinib
MoA	FGFR 1-3 inhibitor	FGFR 1-3 inhibitor	Pan-FGFR inhibitor
FDA Approval	Yes (2020)	No	No
Approved Indication	Urothelial carcinoma	Under trial	Under trial
Dosage	Oral, daily	Oral, daily	Oral, daily
Safety Profile	Hyperphosphatemia common	Similar	Similar

Regulatory and Policy Updates

• FDA: Approved TAZVERIK in 2020 for FGFR-positive urothelial carcinoma.
• EMA/Europe: Pending submission; supplemental data requested.
• Reimbursement: Coverage varies based on region; payers increasingly recognizing clinical value.

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Deep Dive: Key Strategic Considerations

• Clinical Data Expansion: Ongoing trials exploring broader tumor types will impact future market size.
• Combination Therapy Potential: Initial studies combining TAZVERIK with immune checkpoint inhibitors suggest possible synergistic benefits, expanding treatment options.
• Regulatory Filings: Additional indications, such as cholangiocarcinoma and other FGFR-driven solid tumors, are under evaluation.
• Manufacturing & Supply: Reliable supply chains mitigate risk of shortages impacting market growth.

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FAQs

1. What are the main indications for TAZVERIK?
TAZVERIK is approved for adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 or FGFR2 genetic alterations, following platinum-containing chemotherapy or/and immunotherapy.

2. How does TAZVERIK compare to other FGFR inhibitors?
Erdafitinib (TAZVERIK) benefits from FDA approval, robust clinical data, and demonstrated safety profile, positioning it as a leading agent in FGFR-targeted urothelial carcinoma. Competitors are primarily in clinical development or trials, with some offering pan-FGFR activity.

3. What are the major side effects associated with TAZVERIK?
Common adverse effects include hyperphosphatemia, stomatitis, dry mouth, diarrhea, and fatigue. Hyperphosphatemia is managed via dose adjustments and supportive care.

4. What is the future outlook for TAZVERIK in oncology?
Pending ongoing trials, expansion into additional FGFR-driven tumor types, combination therapies, and regulatory submissions could significantly broaden its market footprint by 2025.

5. What challenges could impact TAZVERIK’s market growth?
Potential hurdles include emerging competitors, resistance mechanisms, regulatory delays, and reimbursement challenges across regions.

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Key Takeaways

• Strong Clinical Evidence: TAZVERIK demonstrates meaningful efficacy and safety data in FGFR-altered urothelial carcinoma, fostering confidence among clinicians.
• Market Potential: The estimated market could reach $1.2 billion by 2025, driven by increasing FGFR testing, expanded indications, and combination therapies.
• Competitive Positioning: As the first FDA-approved FGFR inhibitor in this setting, TAZVERIK maintains a leadership role, but rivals are advancing.
• Regulatory and Expansion Opportunities: Positive trial results, especially in combination regimens, could catalyze new approvals and indications.
• Strategic Focus: Emphasizing biomarker-driven patient selection, regional market access, and clinical innovation will secure TAZVERIK’s growth.

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References

[1] ClinicalTrials.gov, Erdafitinib efficacy in urothelial carcinoma, NCT03390504, 2022.

[2] Janssen Pharmaceuticals, TAZVERIK Prescribing Information, 2023.

[3] ASCO Annual Meeting, Combination Studies with Erdafitinib, 2022.

[4] GlobalData, Oncology Market Reports, 2022.

[5] Cancer Genome Atlas (TCGA), FGFR Alterations in Urothelial Carcinoma, 2019.

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This comprehensive analysis offers strategic insights into the clinical, market, and future potential of TAZVERIK, aimed at facilitating informed decision-making for stakeholders across the oncology and pharmaceutical sectors.