Olaratumab
Pronunciation: pronunciation varies by local usage.
- Generic name
- olaratumab
- Brand names
- Lartruvo
- Drug class
- Platelet-derived growth factor receptor alpha (PDGFR-α) blocking monoclonal antibody
- Form
- Injection for intravenous infusion (clinician-administered)
- Route
- Intravenous infusion
- Legal status
- Withdrawn from the market; biologics license revoked in the United States
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What olaratumab is and how it works
Olaratumab was a monoclonal antibody that blocked platelet-derived growth factor receptor alpha (PDGFR-α). It received accelerated FDA approval in 2016 for advanced soft tissue sarcoma in combination with doxorubicin, but was withdrawn from the global market in 2019 after a confirmatory trial failed to show a survival benefit. The US biologics license was formally revoked in 2020. (1) (2) (3)
Olaratumab is no longer available for new patients. It was historically used as a clinician-administered intravenous infusion for eligible adults with advanced soft tissue sarcoma. It was never a self-administered medicine.
Mechanism of action: how olaratumab works
Olaratumab is a monoclonal antibody that blocks platelet-derived growth factor receptor alpha (PDGFR-α), a receptor involved in tumor growth and angiogenesis pathways. (4) (1)
What olaratumab is used for
Advanced soft tissue sarcoma (historical)
Olaratumab was indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen was appropriate, and which was not amenable to curative treatment with radiotherapy or surgery. This was a historical indication during the period the product was marketed; the medicine is now withdrawn. (1) (4)
Before taking olaratumab
Do not take / not appropriate for
- This medicine is no longer available for new patients. The safety and efficacy profile was established during the period it was marketed (2016-2019) and should be discussed with the treating oncologist for any historical context. (all products) (1) (2)
Tell your clinician about
- This medicine is withdrawn. Any discussion about past treatment should be with the oncologist who managed the care.
How to take olaratumab
- Olaratumab was administered as an intravenous infusion by a healthcare professional; it was never intended for self-administration or home use.
- The historical dosing schedule was 15 mg/kg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle, continued until disease progression or unacceptable toxicity.
- Premedication with diphenhydramine and dexamethasone was given prior to the first infusion.
- This medicine is no longer available for new patients.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (4) (3)
Missed dose
This medicine is withdrawn and no longer administered. For historical context, refer to the original prescribing information or discuss with the treating oncologist.
Overdose
This medicine is withdrawn. Any concern about a past administration error should be discussed with the responsible oncologist. (4)
Side effects
The most common adverse reactions reported during the period olaratumab was marketed (in at least 20% of patients receiving olaratumab plus doxorubicin) included nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Infusion-related reactions occurred in 14% of patients across clinical trials.
Infusion-related reactions
What to notice: Flushing, shortness of breath, severe difficulty breathing, or fever/chills, most often during or after the first or second infusion.
What to do: Historically managed by the treating clinician, including infusion interruption or rate reduction for mild reactions and permanent discontinuation for severe reactions. (4)
Severe infusion reaction
What to notice: Severe difficulty breathing, anaphylaxis-like symptoms during or shortly after infusion.
What to do: Historically required immediate clinician intervention and permanent discontinuation of olaratumab. (4)
Serious warnings
Infusion-related reactions — emergency
Symptoms: Severe difficulty breathing, flushing, fever, chills, or anaphylaxis-like symptoms during or shortly after infusion.
Action: This medicine is withdrawn from the market and is not available for new patients. Anyone still receiving olaratumab under a historical access arrangement who experiences these symptoms during or shortly after an infusion should seek emergency medical attention immediately; the treating clinical team manages any interruption or discontinuation. (4)
Pregnancy — warning
Symptoms: Historical labeling warned that olaratumab could cause fetal harm.
Action: This medicine is withdrawn. For historical context, effective contraception was advised during treatment and for 3 months after the last dose. (4)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Doxorubicin and other chemotherapy | Olaratumab was administered in combination with doxorubicin; toxicity and adverse-event profiles reflected the combination. | This medicine is withdrawn. For historical context, treatment decisions were managed by the treating oncologist. (4) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Historical labeling warned that olaratumab could cause fetal harm; effective contraception was advised during treatment and for 3 months after the last dose. This medicine is withdrawn. (4)
Breastfeeding
The US prescribing information stated that there are no data on the presence of olaratumab in human milk, or on its effects on a breastfed infant or on milk production, and that because of the potential risk of serious adverse reactions in breastfeeding infants women should be advised not to breastfeed during treatment with olaratumab and for 3 months after the last dose. Olaratumab has since been withdrawn, so this is historical labelling information rather than current treatment advice; anyone with a question about past exposure should raise it with their clinician.
Monitoring
Before starting
- Not applicable — this medicine is withdrawn and no longer available for new patients.
During treatment
- Not applicable — this medicine is withdrawn. For historical context, monitoring during infusion and throughout treatment cycles was managed by the treating oncologist.
Storage
Not applicable. This medicine is withdrawn from the market and is no longer available for new patients.
Professional information
Clinician-facing historical context only. Olaratumab (Lartruvo) is withdrawn from the global market; the US biologics license was revoked in 2020. This information is provided as a historical reference only and does not constitute a current treatment recommendation.
United States (historical)
Indication: Advanced soft tissue sarcoma
Dose summary: Historical dosing (while marketed 2016-2019): 15 mg/kg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle, with premedication (diphenhydramine and dexamethasone) prior to the first infusion. Continued until disease progression or unacceptable toxicity.
Renal context: The 2016 US label reports that mild to moderate renal impairment (creatinine clearance 30 to 89 mL/min by Cockcroft-Gault) had no clinically important effect on olaratumab pharmacokinetics, and it specifies no renal dose adjustment. Pharmacokinetics in severe renal impairment (CLcr 15 to 29 mL/min) were never characterised and remain unknown. This is historical labelling: the product was withdrawn after the confirmatory trial failed, so any use question belongs with a specialist and current prescribing references.
Overdose note
Frequently asked questions
Is olaratumab (Lartruvo) still available?
No. Olaratumab was withdrawn from the global market in 2019 after a confirmatory Phase 3 trial (the ANNOUNCE study) failed to show a survival benefit. The US biologics license was formally revoked by the FDA in February 2020. It is no longer available for new patients. (1) (2) (3)
Why was olaratumab withdrawn?
Olaratumab received accelerated FDA approval in 2016 based on promising Phase 2 data suggesting a survival advantage when added to doxorubicin. A larger confirmatory Phase 3 trial (ANNOUNCE) failed to confirm any overall-survival benefit, and Eli Lilly voluntarily withdrew the drug from the global market in 2019. The withdrawal was due to insufficient clinical evidence of efficacy, not a new safety signal. (3) (1)
Who manufactured olaratumab?
Lartruvo (olaratumab) was developed and marketed by Eli Lilly and Company. Eli Lilly voluntarily withdrew the product and the FDA later revoked the biologics license. (1) (2)
What is the mechanism of action of olaratumab?
Olaratumab is a monoclonal antibody that blocks platelet-derived growth factor receptor alpha (PDGFR-α), a receptor involved in tumor growth and angiogenesis pathways. (4) (1)
References
- Lartruvo (olaratumab) FDA Approval HistoryDrugs.com · United States · accessed 2026-08-05 · source 1
- Eli Lilly and Co.; Announcement of the Revocation of the Biologics License for LARTRUVOU.S. Federal Register (FDA) · United States · dated 2020-07-17 · accessed 2026-08-05 · source 2
- Lilly to withdraw FDA-approved cancer drug after clinical failureBioPharma Dive; OncLive · United States · accessed 2026-08-05 · source 3
- Lartruvo (olaratumab) prescribing information (historical)Drugs.com; RxList (historical prescribing information) · United States · accessed 2026-08-05 · source 4
Brand names by country
Single-ingredient olaratumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.