Last updated: February 13, 2026
Overview
NDC 50742-0115 corresponds to Lartruvo (olaratumab), a monoclonal antibody developed for soft tissue sarcoma. The drug gained FDA approval in 2016 but faced limited market penetration due to safety concerns and competitive landscape shifts. As of 2023, the drug's market presence remains modest, with limited sales data and commercial availability.
Regulatory Status and Market Context
- Lartruvo was approved by the FDA in 2016 for advanced soft tissue sarcoma, in combination with doxorubicin.
- In 2019, the FDA's Oncologic Drug Advisory Committee (ODAC) recommended withdrawal of Lartruvo's soft tissue sarcoma indication due to lack of efficacy observed in confirmatory trials.
- The FDA subsequently withdrew the approval in 2019 (per FDA communication).
- Despite withdrawal, some compounding or off-label use may persist in niche markets, but these are not reflected in formal market estimates.
Market Size and Demand
- Soft tissue sarcoma is a rare disease with approximately 12,750 new cases annually in the U.S. (per SEER data).
- Estimated total market for targeted therapies in soft tissue sarcoma: approximately $150-200 million annually.
- Lartruvo's initial sales (2017-2018) peaked at around $20 million before decline.
- The market for monoclonal antibodies targeting sarcoma shrinks further due to safety profiles and competition from newer therapies.
Competitive Landscape
- Existing approved treatments include Pazopanib (Votrient), which had annual sales exceeding $300 million in 2019.
- Emerging therapies are focused on immunotherapy and targeted kinase inhibitors.
- Lartruvo's market share has evaporated post-withdrawal.
Price Analysis
- Initial pricing at launch was approximately $8,000 per infusion.
- Dose: 15 mg/kg on days 1 and 8, then every 3 weeks.
- Cost per infusion varies; typical treatment involves 6 infusions per cycle, with an average of 4 cycles per patient.
- Estimated cost per course: approximately $192,000.
Price Projections (2023-2028)
Given the regulatory withdrawal and market exit, formal sales are negligible. However:
| Year |
Scenario |
Estimated Market Price per Dose |
Justification |
| 2023 |
Zero sales |
N/A |
No approved product, no commercialization. |
| 2024 |
Niche/Off-label use |
$8,000 |
Cost-based pricing remains, no regulatory approval. |
| 2025 |
Potential re-approval or new indication |
$8,000-$10,000 |
Price stability or slight increase with marketing re-engagement. |
| 2026-28 |
Market re-entry (speculative) |
$8,000-$10,000 |
Dependent on regulatory decisions; unlikely without new clinical data. |
Key Uncertainties
- FDA approval status: Withdrawal process completed in 2019; no re-approval as of 2023.
- Market demand: Limited unless a new indication emerges or a new formulation is developed.
- Competition: Strong, with newer agents like Pazopanib and immunotherpies.
Conclusion
Market presence for NDC 50742-0115 is minimal post-2019 withdrawal. Price remains historically around $8,000 per dose, with no significant growth projection unless regulatory or clinical developments reopen the market.
Key Takeaways
- Lartruvo's market discontinued following FDA withdrawal in 2019; no current formal sales.
- Price per dose historically averaged $8,000; potential for slight upward adjustments if re-approval occurs.
- The overall soft tissue sarcoma treatment market remains small, with established leaders like Pazopanib.
- Market risk remains high absent new clinical evidence or regulatory approval.
- Long-term price projection remains static unless significant regulatory or clinical changes occur.
FAQs
1. Can Lartruvo be used outside of approved indications?
Off-label use may occur but is not authorized by regulators and lacks consistent reimbursement.
2. What factors could lead to re-approval of Lartruvo?
New clinical trials demonstrating efficacy, safety data reassuring regulators, or supplemental indications could prompt re-approval.
3. How does the competition affect Lartruvo’s potential market?
Existing drugs like Pazopanib and emerging immunotherapies dominate the market, reducing Lartruvo's potential share even if re-approved.
4. What are the main barriers to Lartruvo’s market re-entry?
Regulatory concerns following efficacy data, safety profile issues, and market entrenched competition.
5. Are there any ongoing clinical trials involving olaratumab?
No significant trials are publicly registered as of 2023, indicating limited ongoing development efforts.
Sources
- FDA Drug Approvals and Withdrawals [2]
- SEER Cancer Statistics, 2022 [3]
- IQVIA Sales Data, 2017-2019 [4]
- Market Analysis Reports, 2022 [5]
[2] https://www.fda.gov/drugs/drug-approvals-and-databases
[3] https://seer.cancer.gov/statistics/
[4] IQVIA, 2017-2019 data
[5] Market Research Future, 2022
