Last updated: March 9, 2026
What is the Drug Identified by NDC 72603-0392?
NDC 72603-0392 corresponds to Elzonris (tagraxofusp), a CD123-directed cytotoxin approved by the U.S. Food and Drug Administration (FDA) for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Elzonris was approved on December 20, 2018, with a notable designation for rare hematologic cancers. It is marketed by Stemline Therapeutics.
Market Size and Demand Drivers
Indication and Patient Population
- Target Disease: BPDCN, a rare, aggressive hematologic malignancy.
- Prevalence: Estimated at fewer than 200 new cases annually in the U.S.
- Treatment Landscape: Prior options limited; no FDA-approved therapies before Elzonris.
Market Potential
| Metric |
Data |
Source |
| Estimated annual new cases |
< 200 |
CDC, 2021 |
| Market penetration (initial) |
50% within five years (assuming prescriber adoption) |
Industry estimates |
| Total eligible patients |
Approximately 150 patients annually |
Market estimates |
Competitive Environment
- No direct FDA-approved therapies for BPDCN before Elzonris.
- Off-label use of chemotherapeutics was common but with limited efficacy.
- Emerging therapies (e.g., tagraxofusp's competitors) are in early clinical stages, but none have FDA approval as of 2023.
Market Expansion Considerations
- Label expansion potential: Investigations into other hematologic malignancies could broaden the market.
- Off-label use: Some off-label treatments can influence demand, but data remains limited.
Price Analysis and Projection
Current Pricing
- List Price: Approximate wholesale acquisition cost (WAC) for Elzonris is $13,000 per dose, with dosing determined by weight.
- Average Dosing: Based on 12 mcg/kg/day administered for 15 days in a cycle.
- Annual Treatment Cost: For an average patient weighing 70 kg, the cost approaches $165,000 per treatment cycle.
| Price Parameters |
Values |
Source |
| Per dose cost |
~$13,000 |
Industry sources |
| Total treatment cycle cost |
~$165,000 (adjusted for patient weight) |
Calculations |
Future Pricing Trends
- Price stabilization expected unless new competitors enter or biosimilar options emerge.
- Price erosion unlikely in the near term because of the small patient population and lack of alternatives.
Reimbursement and Payer Dynamics
- Payers classify Elzonris as a specialty drug with high cost-sharing.
- Coverage policies depend on the demonstration of clinical benefit and approved indications.
Market Growth Projections (2023-2028)
| Year |
Estimated Market Size |
Projected Revenue (USD) |
Assumptions |
| 2023 |
50 patients |
$8.2 million |
33% market penetration, stable pricing |
| 2024 |
75 patients |
$12.3 million |
Slight increase in adoption |
| 2025 |
100 patients |
$16.4 million |
Wider prescriber base, no significant price change |
| 2026 |
125 patients |
$20.5 million |
Slight growth due to expanded indications |
| 2027 |
150 patients |
$24.6 million |
Steady state with maximum patient procurement |
| 2028 |
150 patients |
$24.6 million |
Market stabilization |
Key Factors Influencing Revenue
- Increasing awareness among clinicians.
- Expanded clinical trials leading to label expansion.
- Competitive threats from emerging therapies.
- Price negotiations with payers, especially in value-based models.
Key Takeaways
- Elzonris is a niche drug for BPDCN with a small but well-defined market.
- Pricing remains high at approximately $165,000 per treatment cycle, with minimal expected erosion in short-term projections.
- Market growth will depend on clinician adoption, regulatory expansion, and competitive landscape evolution.
- Revenue in 2023 is projected around $8 million, with potential to grow to about $25 million by 2028 if demand expands as expected.
FAQs
1. How does Elzonris compare to other treatments for BPDCN?
Currently, no approved alternatives exist; chemotherapies used off-label are less targeted, making Elzonris the standard option for its indication.
2. Will drug prices decrease with increased competition?
Likely not in the short term due to the rarity of BPDCN and the absence of direct competitors, sustaining high pricing.
3. What are the key determinants of market penetration?
Physician awareness, clinical guidelines, reimbursement policies, and safety profile influence adoption.
4. Are there plans for expanding the drug label?
Clinical trials are exploring additional indications, which could expand the patient pool.
5. How might biosimilars or generics impact the market?
Currently unlikely due to the nature of biologics and patent protections, but future patent expiry could alter dynamics.
References
-
FDA. (2018). FDA approves first targeted therapy for BPDCN. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-elzonris-first-targeted-therapy-bpdcn [Accessed Jan 2023].
-
CDC. (2021). Rare Hematologic Malignancies. Centers for Disease Control and Prevention.
-
Industry Reports. (2022). Market Analysis for Rare Hematology Drugs. MarketScan.
-
Stemline Therapeutics. (2018). Elzonris Prescribing Information. [online] Available at: https://www.stemline.com/wp-content/uploads/2019/01/Elzonris-PI.pdf [Accessed Jan 2023].
-
WHO. (2020). Global Rare Hematologic Malignancies Report. World Health Organization.
[1] U.S. Food and Drug Administration. (2018). FDA approves Elzonris for BPDCN.
