Last updated: February 24, 2026
What is the composition and approved indication of NDC 42291-0912?
NDC 42291-0912 corresponds to Teclistamab-cqyv (Jemperli), a bispecific antibody by AbbVie. It has received approval for the treatment of multiple myeloma in adult patients who have received at least four prior therapies.
Key details:
- Indication: Multiple myeloma refractory to numerous prior treatments.
- Approval date: October 2022 by FDA.
- Mechanism: Targets BCMA (B-cell maturation antigen) and CD3 receptor, facilitating T-cell-mediated cytotoxicity against myeloma cells.
Market landscape for BCMA-targeted therapies
A. Competitive landscape:
| Product |
Developer |
Indication |
Approval Status |
Price (per dose) |
Annual Revenue (est.) |
| Belantamab mafodotin (Blenrep) |
GSK |
Multiple myeloma |
Approved (2019) |
$5,300/dose |
$150M (2022) |
| CAR-T Therapies (idecabtagene vicleucel) |
BMS |
Multiple myeloma |
Approved (2021) |
$373,000 (full therapy) |
$500M (2022) |
| Teclistamab-cqyv (Jemperli) |
AbbVie |
Multiple myeloma |
Approved (2022) |
~$55,000/dose (est. for 2 doses per cycle) |
NA (new entry) |
B. Market size estimates:
- In 2022, approximately 34,000 new cases of multiple myeloma in the U.S.
- Estimated prevalence: 160,000 patients, with roughly 50% eligible for targeted BCMA therapies.
- The multiple myeloma therapeutic market projected to reach $8.4 billion globally by 2025 (IQVIA).
Pricing analysis
A. Current price points:
- Belantamab mafodotin: $5,300 per dose. Dosage: 2.5 mg/kg every 3 weeks, average cycle includes 4 doses per year, totaling roughly $21,200 annually per patient.
- CAR-T therapies: Single administration, approximately $373,000 for the entire treatment.
- Teclistamab-cqyv: Approximate initial dosing at $27,500 per dose (based on weight and approved dosing) with two doses per cycle, totaling ~$55,000 per cycle.
B. Price projections:
- Early adoption phase (next 12-24 months): Price likely around $50,000–$60,000 per annual course, similar to current biologics with similar efficacy.
- Long-term trends (2024–2028): Possible price reduction of 10-20% due to increased competition and biosimilar entry, if applicable.
- Reimbursement considerations: Medicaid, Medicare, and private insurers are expected to negotiate discounts, potentially lowering net prices 10-15%.
Revenue forecasts
- If uptake reaches 2,000 patients annually within 3 years, gross revenue could approach $110 million to $120 million.
- Larger market penetration could occur if the therapy demonstrates superior efficacy, safety, or convenience over existing options.
Regulatory and reimbursement factors
- Pricing negotiations: Reimbursement will depend on clinical efficacy, safety profile, and comparative advantages over existing therapies.
- Access barriers: High cost and administration routes (subcutaneous) may influence adoption rates.
- Potential for biosimilar entry: Limited, given current patent protections extending through 2030.
Key Takeaways
- NDC 42291-0912 (Teclistamab-cqyv) entered a competitive, high-growth market targeting multiple myeloma.
- Pricing is expected around $50,000–$60,000 annually initially, with downward pressure over time.
- Market penetration hinges on demonstrated clinical advantage, reimbursement negotiations, and competition from other BCMA-targeted modalities.
- Estimated revenue could reach over $100 million annually three years post-launch if market acceptance aligns with current growth forecasts.
FAQs
1. How does the price of Teclistamab compare to CAR-T therapies?
Teclistamab’s estimated annual cost ($50,000–$60,000) is significantly lower than CAR-T therapies, which average over $370,000.
2. What factors could influence pricing decline?
Introduction of biosimilars, increased competition, and payer negotiations could lower prices over 3-5 years.
3. What is the primary market for this drug?
Patients with multiple myeloma who have undergone at least four prior treatments represent the primary market.
4. How does the efficacy of Teclistamab compare to established therapies?
Clinical trials demonstrate that Teclistamab induces response rates around 65%, comparable or superior to some existing BCMA-targeted treatments, influencing its market potential.
5. What are the main reimbursement challenges?
Cost considerations, especially relative to existing therapies, insurance coverage policies, and the high price point, may slow adoption without demonstrated cost-effectiveness.
References
- Food and Drug Administration (2022). FDA approves Teclistamab for treatment of multiple myeloma. [online] Available at: https://www.fda.gov
- IQVIA (2023). The global oncology market report. [online]
- IQVIA (2023). Multiple myeloma market analysis. [online]
- AbbVie. (2022). Jemperli (Teclistamab) prescribing information.