Last updated: February 24, 2026
What is NDC 24208-0486?
NDC 24208-0486 identifies a specific drug product within the U.S. healthcare system. It corresponds to Sotorasib (Lumakras), marketed by Amgen. Sotorasib is a targeted therapy approved for adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
Market Landscape
Therapeutic Area and Indication
- Indication: Treatment of KRAS G12C-mutated locally advanced or metastatic NSCLC.
- Market Size (2023): Approximately 200,000 patients annually in the U.S., with about 13-23% of NSCLC cases exhibiting the KRAS G12C mutation (Yuan et al., 2020).
Competitive Environment
Market Adoption Factors
- Clinical efficacy: Demonstrated response rates of approximately 37% in clinical trials.
- Safety profile: Generally manageable, with common adverse events including diarrhea and fatigue.
- Diagnostic testing: Companion tests for KRAS G12C mutation drive patient selection.
- Pricing strategy: Pricing often aligned with targeted therapies, considering the unique mutation for personalized medicine.
Pricing Overview (2023)
Current List Price
- Initial pricing: Approx. $17,500 per month.
- Annual cost: ~$210,000.
Comparative Pricing
| Drug |
Price per Month |
Annual Cost |
Indication |
Approval Date |
| Sotorasib |
$17,500 |
$210,000 |
KRAS G12C-mutant NSCLC |
May 2021 (FDA) |
| Adagrasib |
~$16,500 |
~$198,000 |
KRAS G12C-mutant NSCLC |
Dec 2022 (FDA) |
Insurance and Reimbursement
Coverage typically depends on prior approval processes. The high cost influences reimbursement policies, with payers scrutinizing clinical benefit data.
Market Projections (2023–2028)
Sales Estimates
- 2023: $400 million
- 2024: $700 million
- 2025: $1.1 billion
- 2026: $1.6 billion
- 2027: $2.1 billion
- 2028: $2.7 billion
Assumptions
- Steady increase in diagnosed patients.
- Growing acceptance among oncologists.
- Expanded use in earlier lines of therapy.
- Payer reimbursement strategies favoring targeted therapy.
Growth Drivers
- Increased diagnostic testing: KRAS mutation screening improves patient identification.
- Extension into first-line therapy: FDA approval for first-line treatment boosts volume.
- Competitive pressures: Adagrasib and pipeline agents may restrain rapid growth but still support market expansion.
Risks and Opportunities
Risks
- Competition from emerging pipeline agents.
- Potential updates to clinical guidelines reducing reliance on monotherapies.
- Cost containment measures reducing reimbursement levels.
Opportunities
- Combination regimens to improve response rates.
- Broader indications, including other cancers with KRAS G12C mutation.
- Personalized medicine trends favor targeted therapies.
Key Takeaways
- NDC 24208-0486 (Sotorasib) has established a niche with high unmet needs in KRAS G12C-mutant NSCLC.
- Price remains stable at around $17,500 per month, reflecting targeted therapy standards.
- Market projections suggest a growth trajectory driven by expanding diagnostic and therapeutic landscapes.
- Competitive pressure is emerging with agents like Adagrasib, but Sotorasib retains a strong market position.
- Cost and reimbursement policies will significantly influence long-term adoption and market expansion.
FAQs
Q1: What are the main factors influencing Sotorasib’s price?
Pricing is driven by its targeted indication, clinical efficacy, manufacturing costs, and competitive positioning relative to similar therapies.
Q2: How does the market size for KRAS G12C-mutant NSCLC evolve?
The target population is expanding with increased testing and broader treatment lines, fueling market growth from approximately $400 million in 2023 to over $2.7 billion by 2028.
Q3: Are there efforts to lower the drug’s cost?
Reimbursement negotiations, biosimilar developments, and value-based pricing strategies could impact future pricing, but currently, Sotorasib maintains high launch prices.
Q4: What role does diagnostic testing play?
KRAS mutation testing is essential for identifying eligible patients, thereby directly impacting market penetration.
Q5: How do pipeline agents impact future projections?
New entrants may offer competitive advantages through better efficacy or safety profiles, potentially curbing Sotorasib’s market share over time.
References
[1] Yuan, T., et al. (2020). KRAS G12C mutation in non-small cell lung cancer: Epidemiology, targeted therapy, and mechanisms of resistance. Cancer Treatment Reviews, 91, 102095.
[2] U.S. Food and Drug Administration (2021). FDA approves sotorasib for KRAS G12C-mutated NSCLC.
[3] Market projections derived from industry reports and company earnings statements, 2023–2028.
