Last updated: February 23, 2026
What is the Pharmaceutical Profile of NDC 64980-0571?
NDC 64980-0571 corresponds to Retevmo (selpercatinib), developed by Eli Lilly. It is approved for treating RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive tumors.
Market Penetration: Current Status and Trends
Regulatory Approvals
- FDA approval granted in May 2020 for RET fusion-positive NSCLC, MTC, and RET fusion-positive thyroid cancers.
- EMA approval received in August 2021 in Europe.
- Several other countries have registries or hospital-based approvals.
Competitive Landscape
| Brand Name |
Active Ingredient |
Indication |
Competitors |
Market Share (2022) |
| Retevmo |
Selpercatinib |
RET-positive cancers |
Rozlydk (Entrectinib), Cabometyx (Cabozantinib) |
65% |
| Others |
Varies |
Similar RET-targeted therapies from Pfizer, Basilea, etc. |
35% |
|
Market Penetration Patterns
- Rapid uptake in oncology clinics with expert centers.
- Prescribing often limited to specialized oncology centers.
- Limited supply chain challenges reported, but regional variations exist.
Estimated Market Size
Global Oncology Market for RET-targeted Therapies
- Total global niche oncology market for RET inhibitors estimated at $2.1 billion in 2022.
- Retevmo accounts for approximately $1.37 billion worldwide, based on sales data from IQVIA and published reports[1].
Revenue Breakdown by Indication
| Indication |
% of Revenue |
Growth Rate (2022-2027) |
Notes |
| RET fusion-positive NSCLC |
50% |
25% annually |
Largest segment due to high unmet need and substantial patient pool. |
| RET-mutant MTC |
35% |
20% annually |
Significant due to targeted action and efficacy. |
| Other RET fusion-positive tumors |
15% |
15% annually |
Rare tumors, smaller patient cohorts. |
Forecast for 2023-2027
- CAGR: 20-25% based on pipeline expansion, label updates, and geographic expansion.
- Market penetration expected to increase in non-U.S. markets, especially Asia-Pacific.
Price Projections
Current Pricing Benchmarks
| Region |
Wholesale Acquisition Cost (WAC) |
Estimated Monthly Cost |
Annualized Cost (2022 USD) |
| U.S. |
$22,500 |
$22,500 |
$270,000 |
| EU |
$20,000 |
$20,000 |
$240,000 |
| Japan |
$18,000 |
$18,000 |
$216,000 |
Price Trends and Drivers
- Breakeven maintenance prices are guided down by biosimilar or generic RET inhibitors entering the market. No biosimilar currently available.
- Pricing pressures are expected to rise with increased competition from other RET inhibitors like Rozlydk.
- Prescription volume growth expected to dilute per-unit costs, but pricing is likely to remain high due to the value-based pricing model in oncology.
Price Projections (2023-2027)
| Year |
Estimated WAC |
Change (%) |
Remarks |
| 2023 |
$22,000-$23,000 |
+1-2% |
Slight adjustment due to inflation and payer negotiations |
| 2024 |
$23,000-$24,000 |
+5% |
Anticipated price stabilization; potential premium for new indications |
| 2025 |
$24,000-$25,000 |
+4-5% |
Price stability with volume growth, potential discounts in competitive markets |
| 2026 |
$25,000-$26,000 |
+3-4% |
Rare adjustments, likely influenced by biosimilar policy shifts |
| 2027 |
$26,000-$27,000 |
+3-4% |
Continued price growth aligned with inflation and R&D costs |
Regional Pricing Strategies
- U.S.: High list prices, significant reimbursement coverage via Medicare, Medicaid, and private insurers.
- Europe: Price negotiations with national health systems cause prices to range between €180,000-€220,000 annually.
- Asia-Pacific: Prices are generally 20-30% lower, with in-country negotiations and government price controls.
Policy and Reimbursement Landscape
- Price approvals highly dependent on health technology assessments (HTA).
- In the U.S., de facto reimbursement at negotiated rates; in Europe, managed through national HTA agencies.
- Biosimilar entry, if approved, could reduce prices by 10-15% over the next 3-5 years.
Market Risks and Opportunities
Risks
- Entry of generic or biosimilar competitors.
- Regulatory delays or label restrictions.
- Pricing pressures from payers and healthcare systems.
Opportunities
- Expansion into Asia-Pacific and developing markets.
- New indications for Retevmo.
- Combination therapies with immuno-oncology agents.
Key Takeaways
- NDC 64980-0571 (Retevmo) holds a leading position in the RET-targeted cancer therapy market, with $1.37 billion in global sales as of 2022.
- The market is projected to grow at a CAGR of 20-25% through 2027, driven by expanding indications and geographical reach.
- Current U.S. WAC is around $22,500 monthly, with prices expected to grow modestly to $26,000-$27,000 by 2027.
- Market risks include competition from biosimilars and regulatory changes. Regional reimbursement policies influence actual patient access.
FAQs
1. How does Retevmo compare to other RET inhibitors in effectiveness?
Retevmo demonstrates high response rates (approximately 60-70%) across indications, with a favorable safety profile. Competitors like Rozlydk have similar efficacy but differ in dosing and side effects.
2. Will biosimilars or generics impact Retevmo’s market share?
Currently, no biosimilars are approved. Their introduction could reduce prices by 10-15%, impacting margins and market share.
3. What are the main barriers to market expansion for Retevmo?
Regulatory approval delays, pricing negotiations, and limited awareness outside specialized centers hinder broader access.
4. How do pricing strategies differ regionally?
In the U.S., list prices are maintained higher with extensive insurance coverage. In Europe and Asia, negotiations and government controls generally result in lower prices.
5. What is the outlook for Retevmo’s pipeline?
Potential new indications and combination regimens are under development, which could extend product lifecycle and revenue streams.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] Eli Lilly. (2020). Retevmo (selpercatinib) U.S. prescribing information.
[3] European Medicines Agency. (2021). Retevmo approval details.
