Last updated: February 15, 2026
What is NDC 59762-5007?
NDC 59762-5007 refers to Monjuvi (tafasitamab-cxix), a monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). It was approved by the FDA in July 2020.
Market Overview
Target Population: Approximately 18,000 cases of DLBCL are diagnosed annually in the U.S. (SEER, 2022 data).
Current Treatment Landscape:
- Standard therapies include chemo-immunotherapy regimens like R-CHOP.
- Patients with refractory or relapsed disease often require salvage chemotherapy followed by autologous stem cell transplant.
- Monjuvi serves as a targeted therapy option for non-transplant eligible patients.
Competition & Alternatives:
- Yescarta (axicabtagene ciloleucel): CAR-T therapy approved for relapsed/refractory DLBCL.
- Breyanzi (lisocabtagene maraleucel): CAR-T therapy.
- Darzalex (daratumumab): off-label use in DLBCL.
- Other monoclonal antibodies and chemotherapy regimens.
Market dynamics:
- The monotherapy approval positions Monjuvi as a niche treatment primarily for patients unfit for aggressive therapies.
- The evolving CAR-T market presents competition but also potential market expansion as combinations and new indications develop.
Market Size & Growth Projections
| Parameter |
Data |
Source |
| U.S. DLBCL incidence annually |
18,000 cases |
SEER, 2022 |
| Percentage of relapsed/refractory patients |
50%-60% |
NCCN Guidelines |
| Percentage unfit for transplant |
20%-30% |
Clinical Data |
| Estimated eligible patients for Monjuvi |
~2,000-3,000 |
Market Estimates |
Projected 5-year growth:
- The relapsed/refractory DLBCL segment is expected to grow at a CAGR of 4%-6%, driven by demographic aging and improved diagnostics.
- Monjuvi's market penetration is constrained by competition from CAR-T therapies but could increase as combination treatments are developed.
Pricing Trends and Projections
Current Pricing:
- List price per treatment cycle: approximately $13,000—$15,000 based on treatment protocols (FDA package insert, 2021).
- Average wholesale price (AWP): roughly $13,400 per vial.
- Cost per treatment course: usually 4-8 vials, resulting in $50,000—$120,000 per patient over the course (depending on dosing and duration).
Price Drivers:
- Monjuvi's pricing remains aligned with other monoclonal antibodies.
- Discounts and rebates influence actual net prices.
- As biosimilars are allowed, price reductions are anticipated over 3-5 years.
Future Price Projections:
| Year |
Estimated Price Range per Course |
Rationale |
| 2023 |
$13,000—$15,000 |
Current list price; minimal change expected short-term. |
| 2025 |
$12,000—$14,000 |
Slight decline expected due to generic/biosimilar entry and market compression. |
| 2030 |
$10,000—$12,000 |
Continued decrease driven by biosimilar competition and negotiations. |
Market Challenges & Opportunities
Challenges:
- Competition from CAR-T therapies with durable responses.
- Cost-effectiveness concerns regarding monoclonal antibody treatment.
- Limited indication scope compared to multi-line therapies.
Opportunities:
- Expansion into earlier lines of therapy or combinatorial regimens.
- Partnering or integrating with CAR-T therapies for personalized treatment plans.
- Price adjustments aligning with market entry of biosimilars.
Key Takeaways
- Monjuvi addresses a niche but sizable segment of relapsed/refractory DLBCL ineligible for transplant.
- The U.S. market is estimated around 2,000-3,000 eligible patients annually.
- Price per course is currently approximately $13,000—$15,000, with anticipated gradual decreases aligned with biosimilar entry.
- Market growth is moderate, between 4%-6% CAGR, influenced by expanding diagnostics and increasing relapsed cases.
- Competitive pressures from CAR-T therapies are significant but do not fully displace monoclonal antibody options, especially in non-transplant candidates.
FAQs
1. How does Monjuvi compare price-wise to CAR-T therapies?
CAR-T therapies like Yescarta and Breyanzi cost $375,000—$450,000 per treatment, significantly higher than Monjuvi’s $13,000—$15,000 per course, influencing treatment choices based on cost and patient eligibility.
2. What is the potential impact of biosimilars on Monjuvi prices?
Biosimilar approval could lead to a 20%-30% price reduction within 3-5 years, further compressing profit margins and market share.
3. Which patient group is most likely to benefit from Monjuvi?
Patients with relapsed or refractory DLBCL who are ineligible for stem cell transplant.
4. Are there ongoing trials expanding Monjuvi’s indications?
Yes, current trials are investigating combination therapies and earlier lines of treatment that could expand its market.
5. What regulatory changes could influence Monjuvi’s market?
Approval of biosimilars, changes in reimbursement policies, or expansion of indications by the FDA could substantially alter the market landscape.
References
- SEER Cancer Statistics, 2022.
- FDA Approval Package for Monjuvi, 2020.
- NCCN Clinical Practice Guidelines in Oncology, DLBCL, 2022.
- Industry reports on CAR-T and monoclonal antibody pricing, 2022.
