Last updated: February 25, 2026
What is NDC 68462-0486?
The National Drug Code (NDC) 68462-0486 corresponds to Dostarlimab-gxly (Jemperli), a monotherapy approved for mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer. It is marketed by GlaxoSmithKline (GSK).
Market Overview
The drug entered the US market in April 2021 after FDA approval. Since then, demand has grown primarily within the oncology segment focusing on endometrial cancers with limited treatment options.
Key Indications:
- dMMR recurrent or advanced endometrial carcinoma
- Certain other cancers with mismatch repair deficiency (off-label potential)
Market Size Estimation
Based on epidemiological data:
| Metric |
Value |
| US annual new cases of endometrial cancer |
66,200[1] |
| Proportion of dMMR cases |
20-30%[2] |
| Estimated eligible patients for Dostarlimab |
13,200–19,860[3] |
Healthcare Spending & Reimbursement
- Average wholesale price (AWP): $11,769 per 1,000 mg[4]
- Typical dosing: 500 mg every 3 weeks for 4 cycles, then 1,000 mg every 6 weeks
- Yearly treatment cost per patient: approximately $100,000–$120,000
Competitive Landscape
Competing Drugs:
- Pembrolizumab (Keytruda): Approved for MSI-H/dMMR tumors
- Nivolumab (Opdivo): Also approved for dMMR tumors
- Other emerging agents targeting similar pathways
Market Share and Position
- GSK's Dostarlimab has a niche based on specific indications.
- Keytruda leads in market share with broader oncology approvals.
- Reimbursement and payer restrictions favor established drugs.
Price Positioning
- GSK set a premium pricing model aligned with other immunotherapies.
- Discounting strategies vary by payer contracts.
Price Projections (Next 3-5 Years)
Assumptions:
- The US tumor prevalence remains stable.
- Reimbursement policies stay consistent.
- No major entry of equivalent or superior therapies.
- Uptake rate reaches 70% of eligible patients within 5 years.
| Year |
Estimated Patients Treated |
Revenue (at current price) |
Price Adjustments |
Notes |
| 2023 |
6,500 |
$650 million |
Stable |
Initial market adoption |
| 2024 |
8,000 |
$800 million |
Slight increase |
Expanded indications, payor negotiations |
| 2025 |
10,000 |
$1 billion |
Slight decrease |
Price stabilization, increased competition |
| 2026 |
12,000 |
$1.2 billion |
Further decrease |
Market maturation, volume growth |
Influencing Factors:
- Market penetration: Limited by current indications.
- Price negotiations: Payers may push for discounts, especially if biosimilar competition emerges.
- Regulatory dynamics: Additional approvals could expand market size.
- Biotechnology advances: Emerging therapies could pressure prices downward.
Regulatory and Policy Considerations
- No biosimilar approvals for Dostarlimab as of the latest update.
- Price regulation pressures via the Inflation Reduction Act may impact net prices.
- Payer coverage policies tend toward narrow formulary inclusion.
Key Takeaways
- The US market for Dostarlimab is expected to generate approximately $650 million by 2023, growing to over $1.2 billion by 2026 under current conditions.
- Price levels are likely to stay stable with minor decreases due to market maturation and competition.
- Growth hinges on expansion into additional indications and increased patient access.
- Competition from Keytruda and other immunotherapies remains significant.
FAQs
Q1: What factors most influence Dostarlimab’s market share?
A1: Indication expansion, reimbursement policies, and competition from established drugs like Keytruda.
Q2: How will biosimilar entry affect prices?
A2: Biosimilars could force price reductions of 15–25%, depending on regulatory and competitive developments.
Q3: Is Dostarlimab profitable for GSK?
A3: Likely profitable due to high per-dose pricing and targeted patient population, but sensitive to reimbursement rates.
Q4: What are the key hurdles for market growth?
A4: Limited approved indications, payer restrictions, and emerging alternative therapies.
Q5: Are there international markets for Dostarlimab?
A5: Yes, but regulatory approvals and market dynamics vary—Europe and Asia are potential markets with differing timelines.
References
[1] American Cancer Society. (2022). Endometrial Cancer Statistics.
[2] Cancer Genome Atlas Research Network. (2013). Endometrial carcinoma molecular characterization. Nature.
[3] Smith, J. et al. (2021). Estimated US patient population for immunotherapy in endometrial cancer. Journal of Oncology.
[4] Red Book. (2022). Wholesale prices for immunotherapies.
