Last updated: March 2, 2026
What is the Drug?
NDC 68462-0859 corresponds to Tafasitamab-cxix (Monjuvi), a monoclonal antibody developed by MorphoSys and approved by the FDA in August 2020. It treats relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide in adult patients who are ineligible for high-dose chemotherapy.
Market Overview
Patient Population
- Primary indication: Relapsed/refractory DLBCL.
- Estimated U.S. patient population: 10,000 – 15,000 annually based on FDA approval data and epidemiological estimates [1].
Competitive Landscape
- Main competitors include:
- Rituximab (Rituxan)
- Polatuzumab vedotin (Polivy)
- Selinexor (Xpovio)
- CAR-T cell therapies (Kymriah, Yescarta)
- Monjuvi is positioned as an option for patients ineligible for CAR-T therapy or those who need salvage to other treatments.
Market Dynamics
- Monjuvi has a niche, targeting a subset of DLBCL patients ineligible for aggressive treatments.
- The drug's adoption depends on physician familiarity, reimbursement policies, and comparative effectiveness.
Pricing Data
U.S. List Price
- The wholesale acquisition cost (WAC) is approximately $9,563 per 50 mg vial [2].
Dosing and Cost Implications
- Typical dose: 12 mg/kg administered intravenously on days 1, 4, 8, and 15 of cycle 1, followed by every 3-week cycles.
- Example: A 70 kg patient requires 840 mg per cycle, equating to around 17 vials ($162,371 per cycle).
Reimbursement and Net Price
- Actual net price varies depending on negotiations, rebates, and discounts.
- Estimated net prices are approximately 70–80% of the list price, translating to roughly $6,700 – $7,600 per 50 mg vial.
Market Penetration and Revenue Projections
Current Adoption
- As of 2022, an estimated 1,500–2,000 patients have received Monjuvi in the U.S.
- Annual sales reached approximately $125 million in 2022, reflecting slow but increasing adoption [3].
Future Growth Projections
- Projected compound annual growth rate (CAGR) for the next five years: 8–12%.
- Growth driven by:
- Expanded indications (potential for first-line or earlier-line use)
- Increased awareness among physicians
- Entry into international markets
- New combination regimens under clinical trial evaluation
Key Variables Influencing Price and Market Share
| Variable |
Impact |
Source |
| New indications |
Raises potential patient pool |
[1] |
| Competition |
Could reduce market share |
[2] |
| Reimbursement policies |
Affect net pricing |
[3] |
| Manufacturing costs |
Limit price reductions |
Internal analysis |
Risks
- Entry of biosimilars or novel therapies.
- Changes in treatment guidelines.
- AMNOG or price regulation policies abroad.
Regulatory and Policy Environment
- No biosimilars approved yet for Tafasitamab in the U.S.
- International markets face price controls and reimbursement constraints.
- Ongoing clinical trials may expand usage, impacting pricing strategies.
Summary
Monjuvi's market remains niche, with steady growth based on increasing adoption within its approved indication. Its list price remains high, with actual net prices potentially lower. Market expansion depends on clinical trial outcomes, indications, and competitive developments.
Key Takeaways
- The drug's U.S. list price is approximately $9,563 per vial.
- Average annual revenue in 2022 was $125 million, with growth forecasted at 8–12% CAGR.
- Competition and regulatory changes could influence future pricing and market share.
- Entry into broader indications and international markets presents growth opportunities.
FAQs
Q1: How does Monjuvi compare price-wise to similar therapies?
It is priced similarly to other monoclonal antibodies in oncology, with list prices around $9,500 per vial, but net prices are lower due to discounts.
Q2: What are the key factors influencing future price changes?
Clinical expansion, competition, reimbursement environment, and manufacturing costs.
Q3: How many patients are eligible for Monjuvi annually?
Approximately 10,000–15,000 U.S. patients with relapsed/refractory DLBCL.
Q4: What are main alternative therapies?
Rituximab-based regimens, Polatuzumab vedotin, and CAR-T therapies.
Q5: What is the likelihood of biosimilar entry?
Currently low, as no biosimilar has been approved yet; potential exists in the next 3–5 years.
References
[1] American Cancer Society. (2022). Cancer Facts & Figures.
[2] Red Book. (2023). Wholesale Acquisition Cost Data.
[3] IQVIA. (2022). U.S. Prescription Data.
