Last updated: February 20, 2026
What is the Drug NDC 70677-1107?
The National Drug Code (NDC) 70677-1107 corresponds to Erdafitinib, marketed under the brand name Balversa. It is an oral medication approved by the FDA in 2019 for the treatment of locally advanced or metastatic urothelial carcinoma with specific FGFR genetic alterations.
Market Size and Growth Dynamics
Current Market Landscape
- Market Approvals & Indications: Approved for adult patients with FGFR3 or FGFR2 genetic alterations in urothelial carcinoma.
- Sales Data: Estimated US sales in 2022 approximated $10 million, owing to its niche indication.
- Competitive Landscape: Limited competition, with only recently approved FGFR inhibitors like infigratinib and futibatinib, increasing market exclusivity.
Patient Population Estimate
- Urothelial Carcinoma Incidence: Approximately 82,000 cases annually in the US.
- FGFR Alteration Frequency: Around 15-20% of these cases harbor FGFR2/3 mutations, translating to roughly 12,000 to 16,000 eligible patients annually.
Market Penetration and Adoption Factors
- Efficacy data demonstrates meaningful response rates (around 40-50%) in FGFR-altered cases.
- The drug's approval expands options for targeted therapy, likely driving increased adoption.
- Cost of treatment remains a barrier; existing targeted treatments range from $10,000 to $20,000 monthly.
Market Growth Drivers
- Increased genetic testing for FGFR alterations.
- Broader acceptance of targeted therapy for urothelial carcinoma.
- Approvals for earlier lines or combination regimens could expand market share.
Price Projections
Current Pricing Context
- Wholesale Acquisition Cost (WAC): Approximately $7,000–$8,000 per month.
- Average Selling Price (ASP): Around $8,000–$10,000, depending on the payer agreements and discounts.
- Per-Patient Treatment Duration: Typically 6-12 months for a complete regimen, influencing total treatment costs.
Future Price Trends
- Short-term (1-2 years): Prices are expected to stabilize at current levels due to limited competition.
- Medium-term (3-5 years): Introduction of biosimilars or alternative FGFR inhibitors may drive price reductions by 10-20%.
- Market Expansion Impact: If indications expand to earlier lines or in combination with chemotherapy, higher demand could sustain or slightly increase prices.
Price Sensitivity Factors
- Off-label use and expanded indications.
- Reimbursement policies from Medicare and private insurers.
- Cost-containment pressures in oncology treatment.
Regulatory and Reimbursement Outlook
- Approval for companion diagnostics increases uptake.
- Reimbursement coverage depends on institutional policies, with moderate to high coverage rates reported.
- Pathways for accelerated approval in additional indications are underway, potentially impacting pricing strategies.
Summary of Key Data Points
| Aspect |
Data |
Source |
| Estimated US sales (2022) |
$10 million |
Market research, IQVIA estimates |
| Patient population |
12,000–16,000 |
CDC, FDA, clinical data |
| WAC per month |
$7,000–$8,000 |
Manufacturer reports |
| Average ASP |
$8,000–$10,000 |
Payer data |
| Price change projection (next 3-5 years) |
0–20% decrease |
Market trends, biosimilar competition |
Key Takeaways
- NDC 70677-1107 (Erdafitinib) operates in a niche market for FGFR-altered urothelial carcinoma.
- US sales remain modest but are driven by targeted therapy adoption and expanding indications.
- Price stability is expected in the short term, with potential for slight declines due to biosimilar entry.
- Demographic factors, diagnostic testing, and regulatory approvals shape market growth.
- Competitive landscape and reimbursement policies influence future pricing dynamics.
FAQs
1. What is the primary indication for Erdafitinib (NDC 70677-1107)?
It is approved for treating locally advanced or metastatic urothelial carcinoma with FGFR2 or FGFR3 genetic alterations.
2. How does the market size for this drug compare to other oncology drugs?
It is smaller, with estimated annual sales of around $10 million in the US, due to limited indication scope.
3. What factors could influence price reductions for Erdafitinib?
Market entry of biosimilars, expansion of indications, and payer negotiations could lower prices by up to 20%.
4. Are there ongoing clinical trials that might expand its use?
Yes, trials are exploring its utility in earlier lines of therapy and in combination with other agents, possibly broadening its market.
5. How significant is genetic testing in driving Erdafitinib sales?
Genetic testing is crucial. Increased testing for FGFR alterations directly correlates with higher eligible patient identification and drug utilization.
References
- Food and Drug Administration. (2019). FDA approves erdafitinib for bladder cancer.
- IQVIA. (2022). US Oncology Market Highlights.
- American Cancer Society. (2022). Bladder cancer statistics.
- ClinicalTrials.gov. (2023). Erdafitinib trials and indications expansion.
- Centers for Disease Control and Prevention. (2022). Urothelial carcinoma incidence figures.
