LARTRUVO Drug Profile

Summary for Tradename: LARTRUVO

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for LARTRUVO

Recent Clinical Trials for LARTRUVO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Janssen Scientific Affairs, LLC	Phase 1
University of Miami	Phase 1
Columbia University	Phase 2

See all LARTRUVO clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for LARTRUVO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for LARTRUVO Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	8,128,929	2026-06-19	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	8,574,578	2031-10-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for LARTRUVO Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,047,163	2034-02-07	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,111,968	2036-08-10	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,590,182	2036-02-23	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,675,358	2038-09-24	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,751,296	2037-01-25	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038	10,933,061	2038-12-21	Patent claims search

International Patents for LARTRUVO

Country	Patent Number	Estimated Expiration
Japan	2012179060
Israel	198869
Cyprus	2017013
Denmark	2100614
Russian Federation	2009115364
South Korea	20080047529

Supplementary Protection Certificates for LARTRUVO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB17/027	United Kingdom		PRODUCT NAME: OLARATUMAB, A HUMAN IGG1 MONOCLONAL ANTIBODY; REGISTERED: UK EU/1/16/1143 20161111
2017/014	Ireland		PRODUCT NAME: LARTRUVO-OLARATUMAB; REGISTRATION NO/DATE: EU/1/16/1143 20161109
C20170011 00211	Estonia		PRODUCT NAME: OLARATUMAB;REG NO/DATE: EU/1/16/1143 11.11.2016
CA 2017 00015	Denmark		PRODUCT NAME: OLARATUMAB; REG. NO/DATE: EU/1/16/1143/001 20161111
132017000040358	Italy		PRODUCT NAME: OLARATUMAB(LARTRUVO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1143/001, 20161111
C 2017 013	Romania		PRODUCT NAME: OLARATUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1143; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1143; DATE OF FIRST AUTHORISATION IN EEA: 20161109

Market Dynamics and Financial Trajectory for the Biologic Drug: LARTRUVO

Last updated: September 19, 2025

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Introduction

LARTRUVO (olaratumab) emerged as a notable biologic in oncology, specifically targeting soft tissue sarcoma (STS). Developed by Eli Lilly and Company, it represented a novel mechanism—an anti-PDGF receptor alpha (PDGFRα) monoclonal antibody—aimed at inhibiting tumor growth. Despite initial optimism and regulatory approval in the U.S. in 2016, subsequent clinical trials cast doubt on its long-term viability, dramatically influencing its market trajectory. This report assesses the current market dynamics and financial outlook for LARTRUVO amid evolving oncology therapeutics.

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Market Context for LARTRUVO

Therapeutic Indication and Initial Market Entry

LARTRUVO was developed to address unresectable or metastatic soft tissue sarcoma, a complex and heterogeneous group of cancers with limited treatment options. The drug’s FDA approval was based on promising Phase II results, which demonstrated a median overall survival benefit. In 2016, it became the first new agent approved specifically for advanced STS in over two decades, signaling significant potential.

Competitive Landscape and Alternative Treatments

LARTRUVO entered a highly competitive market landscape characterized by:

• Chemotherapy agents: Doxorubicin and ifosfamide remain standard first-line treatments.[1]
• Targeted therapies: Pazopanib, a tyrosine kinase inhibitor, gained approval for non-adipocytic soft tissue sarcomas, providing an oral alternative.[2]
• Immunotherapies: Checkpoint inhibitors like pembrolizumab are under investigation, with evolving evidence for efficacy in sarcomas.[3]

The crowded therapeutic space and incremental advances have constrained LARTRUVO’s market penetration.

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Market Dynamics

Regulatory Shift and Clinical Trial Outcomes

Subsequent Phase III trials failed to confirm the survival advantage originally perceived, leading to a significant reevaluation of LARTRUVO’s efficacy. In 2019, Lilly withdrew the supplemental biologics license application (sBLA) based on these disappointing results, resulting in de-listing from the market in several regions and a halt to further sales in the United States.[4] This regulatory setback fundamentally altered its market outlook.

Commercial Viability and Market Reception

Following the withdrawal, LARTRUVO transitioned from a promising novel therapy to a case study of early optimism overshadowed by late-stage clinical failure. Market reception collapsed, and Lilly shifted focus toward pipeline oncology drugs and other biologics with more promising profiles. The initial launch was characterized by:

• Limited sales and revenue streams: Estimated peak annual sales of approximately $100 million in 2017,[5] though actual sales were significantly lower.
• Pricing set at $13,300 per month per patient: Reflecting the high cost typical of biologic cancer agents but hampered by limited efficacy data and regulatory uncertainties.

Current Status and Future Outlook

LARTRUVO’s market presence effectively ended with the Phase III trial failure. No approvals in new indications or regions are contemplated, rendering it a discontinued or heavily de-prioritized asset. Lilly’s strategic focus has shifted to other biologics and immunotherapies, such as ALLOSANT (alectinib), emphasizing personalized medicine and combination therapies.

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Financial Trajectory and Investment Considerations

Historical Financial Impact

Lilly’s initial R&D investments and relatively modest sales figures depict a typical biotech risk profile:

• R&D investments peaked during early clinical development (~$200 million).[6]
• Post-approval sales reached a limited peak before plummeting after Phase III failures.
• The drug’s discontinuation resulted in financial impairments, including inventory write-offs and impairment charges, impacting Lilly’s oncology segment profitability.

Future Financial Outlook

Given the withdrawal from the market and absence of new indications, LARTRUVO presents negligible revenue prospects. Its financial impact is confined to historical accounting and potential licensing or patent royalties if acquired or licensed by other entities. However, none are currently publicly committed, indicating that LARTRUVO’s contribution to Lilly’s revenue forecast is effectively nil moving forward.

Implications for Biotech Investors and Industry Stakeholders

The LARTRUVO case exemplifies the inherent risks in biologic drug development—early promise does not guarantee clinical benefit or regulatory approval. It underscores the importance of rigorous Phase III validation and post-approval monitoring. For investors, the key takeaways include:

• The necessity of contingency planning in biologic portfolios.
• Recognizing the impact of clinical trial outcomes on valuation.
• The importance of diversified pipelines to mitigate individual asset setbacks.

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Broader Market Trends Affecting Biologic Oncology Drugs

The LARTRUVO experience is emblematic of broader shifts:

• Personalized medicine drive: Increasingly, therapies target specific molecular pathways. Broad-spectrum biologics face declining interest unless linked with companion diagnostics.
• Regulatory rigor: Agencies demand more robust evidence before approval—raising the bar for new biologics.
• Market consolidation: Larger pharmaceutical firms acquire promising biologics earlier in development to control risk and streamline pipelines.

Further, the ongoing COVID-19 pandemic has influenced research priorities and commercialization strategies, emphasizing flexibility in clinical development and lifecycle management.

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Key Takeaways

• Clinical validation is paramount: LARTRUVO’s initial promise was undermined by subsequent clinical failures, illustrating the critical importance of rigorous Phase III trials.
• Market outlook is heavily dependent on regulatory success: Regulatory setbacks can rapidly curtail revenue streams and diminish a drug’s value.
• Competitive landscape constrains market share: Existing standard-of-care therapies and emerging modalities limit the market potential for new biologics.
• Biotech investment carries substantial risk: Early-phase successes do not guarantee commercial viability; continuous evaluation is essential.
• Strategic focus shifts to innovation and pipeline diversification: Firms are increasingly investing in precision medicine, immunotherapies, and combination regimens to sustain growth.

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FAQs

1. What led to LARTRUVO’s withdrawal from the market?
LARTRUVO failed to demonstrate an overall survival benefit in Phase III clinical trials, which prompted Eli Lilly to withdraw its approval application in 2019, effectively removing it from the market.

2. Can LARTRUVO be repurposed for other indications?
Currently, there are no public plans or ongoing research exploring alternative indications for LARTRUVO, and its development has been discontinued.

3. How does the failure of LARTRUVO influence biotech investment?
It accentuates the high-risk nature of biologic development, emphasizing robust trial designs, biomarker validation, and cautious resource allocation toward promising candidates.

4. What lessons can pharmaceutical companies learn from LARTRUVO’s market trajectory?
Companies should prioritize rigorous clinical validation, maintain flexibility to adapt strategies, and diversify pipelines to counterbalance setbacks with promising assets.

5. What is the outlook for biologics targeting soft tissue sarcoma?
The field continues to evolve with novel agents, including immunotherapies and targeted kinase inhibitors, but success hinges on demonstrating clear clinical benefits and overcoming complex tumor heterogeneity.

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References

1. Fletcher CDM, et al. WHO Classification of Tumours of Soft Tissue and Bone. 4th Edition. 2013.
2. van der Graaf WT, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012.
3. Luca B, et al. Immunotherapy in sarcomas: current status and future perspectives. Ther Adv Med Oncol. 2020.
4. Eli Lilly. Lilly’s LARTRUVO (olaratumab) phase III trial halted for futility. 2019.
5. EvaluatePharma. Oncology Biosimilars and Biologics Market Report. 2017.
6. Eli Lilly Annual Report. 2016.

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In conclusion, LARTRUVO’s journey encapsulates both the potential and pitfalls inherent in biologic drug development. While it initially symbolized a promising advancement for soft tissue sarcoma treatment, its inability to validate clinical benefits at the phase III level curtailed its market prospects and financial viability. For stakeholders, its legacy underscores the necessity of rigorous evidence generation, adaptive strategic planning, and continuous innovation within the biologic oncology landscape.