Last updated: February 20, 2026
What is the drug corresponding to NDC 65862-0865?
The National Drug Code (NDC) 65862-0865 corresponds to Tafasitamab-cxix (Monjuvi), a monoclonal antibody indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It targets CD19, a cell surface antigen present on B cells. Approved by the FDA in July 2020, Monjuvi is marketed by MorphoSys and Incyte.
What is the current market size for Tafasitamab-cxix?
Epidemiology
- DLBCL accounts for approximately 25-30% of non-Hodgkin lymphoma cases globally.
- Estimated annual new cases in the U.S.: 22,000–23,000.
- Relapsed/refractory (R/R) DLBCL patients eligible for Monjuvi: approximately 50% of initial cases, translating into about 11,000–12,000 patients annually.
Market Share and Competition
- Upfront treatment usually involves chemoimmunotherapy (e.g., R-CHOP).
- Relapsed/refractory cases often treated with CAR T-cell therapies: Yescarta (Gilead), Kymriah (Novartis).
- Monjuvi's primary competition remains CAR T therapies, which have higher costs but are approved for later lines.
Revenue Potential
- Average wholesale price (AWP): approximately $6,500 per 50 mg vial.
- Typical treatment course: around 6 doses over 3 cycles, costing roughly $39,000 per patient.
- Market penetration is constrained by competition, especially CAR T therapies, and payer restrictions.
What are the price projections for Monjuvi?
Historical Pricing Trajectory
- Launched in 2020 at approximately $6,500 per 50 mg vial.
- Treatment course priced around $39,000.
- Price adjustments are limited due to negotiated rebates and payer discounts.
Short-term Price Trends (Next 1–2 Years)
- Likely to remain stable due to existing pricing agreements.
- Slight discounts or rebates may occur as manufacturers negotiate with payers.
- No indications for substantial price increases expected without new labeling or formulations.
Long-term Price Projections (Next 3–5 Years)
- Competitive pressure from biosimilars is limited; biosimilars for monoclonal antibodies targeting CD19 are not yet in marketing.
- If new indications are approved or combination regimens with higher efficacy are introduced, price adjustments could occur.
- Healthcare inflation and policy changes could influence pricing or reimbursement frameworks.
Impact of Market Dynamics
| Factor |
Effect on Price |
Notes |
| Competition from CAR T therapies |
Holds prices steady |
CAR T therapies cost significantly more but dominate refractory settings |
| Payer negotiations |
Limits upward pressure |
Payer discounting and rebates are common in oncology products |
| New indications or formulations |
Potential price increase |
Expansion beyond current label could justify higher prices |
Risks affecting market and price projections
- Entry of biosimilar monoclonal antibodies targeting CD19 could reduce price and market share.
- Regulatory changes impacting drug reimbursement and pricing policies.
- Advances in alternative therapies potentially diminishing Monjuvi's role.
Key financial metrics
| Metric |
Value/Estimate |
Source |
| Average Wholesale Price (AWP) |
$6,500 per 50 mg vial |
Manufacturer data |
| Treatment Cost per Patient |
~$39,000 |
Based on approved dosing |
| Annual Market Potential in US |
~$250–$300 million |
Estimated from patient numbers and market share |
Summary
- The US market for Tafasitamab-cxix (NDC 65862-0865) centers on R/R DLBCL, with an estimated annual addressable market of 11,000–12,000 patients.
- Current pricing stabilizes around $39,000 per treatment course, with minimal expected short-term changes.
- Long-term price growth is restrained by market competition, payer negotiations, and lack of biosimilar entry.
- Market expansion hinges on new indications, combination therapies, and regulatory developments.
Key Takeaways
- Monjuvi faces stiff competition from CAR T-cell therapies but maintains niche positioning for specific relapsed/refractory cases.
- Pricing remains stable due to existing market dynamics and reimbursement frameworks.
- Market growth is limited by the small size of the R/R DLBCL population and competition.
- Future price changes depend on label expansion, manufacturing innovations, and regulatory shifts.
- The overall market outlook remains cautiously optimistic within current therapeutic and economic constraints.
FAQs
Q1: What determines Monjuvi’s market penetration?
Market penetration depends on physician prescribing habits, payer restrictions, and competition from CAR T therapies, which require advanced cell processing and are priced higher.
Q2: How does pricing compare with competing therapies?
Monjuvi’s treatment course is approximately $39,000, significantly lower than CAR T therapies like Yescarta (~$373,000) and Kymriah (~$475,000), but these therapies are used in later lines of treatment.
Q3: Could biosimilars impact Monjuvi’s market?
Yes, biosimilar monoclonal antibodies targeting CD19 could increase competition and reduce prices in the future, but none are currently available.
Q4: What regulatory developments could influence the market?
New indications, approval of combination regimens, or label expansions could boost demand and allow for price adjustments.
Q5: Are there geographic variations in pricing?
International markets may have different pricing due to local regulations, reimbursement policies, and market size, but detailed global data are limited.
References
[1] U.S. Food and Drug Administration. (2020). FDA approving tafasitamab for certain blood cancers.
[2] IQVIA. (2022). Oncology market data.
[3] MorphoSys. (2020). Monjuvi prescribing information.
[4] CNBC. (2022). CAR T therapies pricing overview.
[5] American Cancer Society. (2022). Diffuse large B-cell lymphoma epidemiology.
