Last updated: February 24, 2026
What Is the Indication for NDC 76282-0570?
NDC 76282-0570 corresponds to the drug Teclistamab-cqyv. It is a bispecific antibody approved by the FDA for treatment of relapsed or refractory multiple myeloma. Approved in October 2022, it is marketed as Tecvayli.
Market Overview
Market Size and Disease Context
Multiple myeloma (MM) is a plasma cell malignancy affecting approximately 44,000 patients annually in the U.S. and 150,000 globally [1]. The disease has seen aggressive growth in treatment options over the past decade, including proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and CAR-T therapies.
Treatment Landscape
- Standard therapies: Proteasome inhibitors, immunomodulators, and monoclonal antibodies.
- Emerging options: Bispecific T-cell engagers (BiTEs) like Tecvayli.
- Competitive drugs: Belantamab mafodotin, CAR-T therapies (e.g., idecabtagene vicleucel), and emerging pipelines.
Market Penetration & Adoption
Since its launch in late 2022, Tecvayli has gained rapid uptake in relapsed/refractory settings, especially among patients refractory to multiple prior lines of therapy.
Revenue Expectations
In 2022-2023, Tecvayli's global sales are projected between $200 million and $300 million [2]. Growth depends on new approvals, line of therapy positioning, and competitive landscape developments.
Price Analysis
Current Price Position
- U.S. Wholesale Acquisition Cost (WAC): Approximately $10,200 per 50 mg dose [3].
- Dosing: For typical adult patients, the recommended dose is 1.5 mg/kg, administered weekly after initial dosing, which influences average annual treatment costs.
Cost Breakdown
Assuming a median patient weight of 70 kg:
- Initial dose: 1.5 mg/kg x 70 kg = 105 mg.
- Frequency: Weekly for the first 2 months, then biweekly or monthly long-term.
- Estimated annual drug cost: $50,000 - $70,000 per patient.
Price Trends and Future Projections
- Development of biosimilars: No biosimilars are currently available, which supports price stability.
- Reimbursement trends: Increasing coverage may stabilize or slightly reduce net prices.
- Potential price adjustments: Biosimilar entry is unlikely within the next 3–5 years; hence, the drug price may stabilize or increase conservatively with inflation and additional indications.
Pricing Comparisons
| Drug |
Indication |
WAC per Dose |
Annual Cost Estimate |
Market Position |
| Tecvayli (NDC 76282-0570) |
Multiple myeloma (relapsed/refractory) |
$10,200 (per 50 mg) |
$50,000–$70,000 |
First in class bispecific antibody |
| Belantamab mafodotin |
Multiple myeloma |
~$8,200 per 200 mg vial |
$40,000–$50,000 |
Monoclonal antibody |
| Idecabtagene vicleucel |
Multiple myeloma (CAR-T) |
~$400,000 per dose |
$400,000+ |
CAR-T therapy with high upfront costs |
Regulatory & Policy Impact on Market and Price
- Reimbursement policies: CMS and private payers emphasize value-based arrangements.
- Potential for price negotiation: Due to high costs, payers may leverage discounts or risk-sharing payments.
- Future approvals: Expanding indications could influence pricing and sales volume.
Key Takeaways
- Tecvayli entered the market in late 2022, targeting an underserved segment in relapsed/refractory multiple myeloma.
- U.S. wholesale price is approximately $10,200 per 50 mg dose, with annual costs around $50,000–$70,000 per patient.
- The market size for Tecvayli is expected to grow, with sales projections reaching $300 million by 2024, assuming steady adoption.
- No biosimilars are available, supporting stable pricing in the near term.
- Competitive dynamics include monoclonal antibodies and CAR-T therapies, impacting dosage, magnitude, and price.
References
- American Cancer Society. (2022). Key statistics for multiple myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html
- Evaluate Vantage. (2023). Tecvayli sales estimates and market outlook. https://www.evaluate.com/
- Red Book. (2023). Wholesale acquisition costs for biotech drugs. Micromedex.
