Lartruvo (olaratumab)

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Lartruvo (olaratumab)

How to buy Lartruvo: You can order Lartruvo (olaratumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Eli Lilly and Co.
Disease Soft-tissue Sarcoma
Indication Soft-tissue Sarcoma
Mode of Action Platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 1024603-93-7
Strength 10 mg/mL

Who is olaratumab for?

Lartruvo (olaratumab) is indicated in combination with doxorubicin for the treatment of patients with soft tissue sarcoma (STS) who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin [1][2]. Doxorubicin is a cancer medication widely approved for the treatment of different forms of cancer [5][6][7].

Recommended dose

Complete information about Lartruvo (olaratumab) dosage and administration can be found here [1][3].
The standard dosage is:
  • 15 mg / kg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
  • Administer in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo monotherapy in patients whose disease has not progressed. Doxorubicin is given on day 1 of each cycle following the Lartruvo (olaratumab) infusion.
Consult your treating doctor for personalised dosing.

What is olaratumab and how does it work?

Lartruvo (olaratumab) is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels, and fat tissue [2]. The active substance in Lartruvo, olaratumab, is a monoclonal antibody that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha’ (PDGFRα). This protein is often found on the surface of cells where it plays a role in regulating cell multiplication. In cancers such as soft tissue sarcoma, this protein is present in high levels or is overactive, causing cells to become cancerous. By attaching to PDGFRα on sarcoma cells, Lartruvo is expected to block the activity of this protein, thereby slowing down the growth of the cancer [2].

What is olaratumab's approval status?

Lartruvo (olaratumab) was approved by:
  • FDA (USA) on October 1, 2016
  • EMA (EU) on November 9, 2016
for the treatment of patients with soft tissue sarcoma (STS)  who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin [2][3][4]

The approvals were based on a study involving 133 adults with advanced soft tissue sarcoma who couldn’t undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin) [2][3][4]. Patients in this trial who received olaratumab with doxorubicin had a statistically significant improvement in overall survival: the median survival was 26.5 months compared to 14.7 months for patients who received doxorubicin alone. Patients who received Lartruvo with doxorubicin had a median progression-free survival (time patients live without their disease getting worse) of 6.6 months compared to 4.1 months for patients who received doxorubicin alone. Tumor shrinkage was 18.2 % for patients who received Lartruvo (olaratumab) with doxorubicin and 7.5 % for those who received doxorubicin alone [3][4].

The most common adverse reactions of Lartruvo (olaratumab) plus doxorubicin are nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache [1][3].
References
[1] Summary of Product Characteristics [FDA]: Lartruvo (olaratumab), Eli Lilly and Co., Oct. 2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf
[2] EMA. EPAR summary for the public. Lartruvo (olaratumab). Nov. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004216/WC500216872.pdf
[3] Summary of Product Characteristics [EMA]: Lartruvo (olaratumab), Eli Lilly Netherland B.V., 05/05/2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004216/WC500216869.pdf
[4] Tap W.D., et al. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. The Lancet. 2016/07/04; 388(10043):488–497.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30587-6/abstract
[5] Drugs.com. Doxorubicin. 28/12/2016 (last updated 01/06/2017), cited on 10/01/2017.
https://www.drugs.com/mtm/doxorubicin.html
[6] EMA. Human Medicines: Caelyx (doxorubicin), 09/03/2008 (last updated: 27/02/2017), cited on 10/01/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000089/human_med_000683.jsp&mid=WC0b01ac058001d124
[7] Summary of Product Characteristics: Caelyx (doxorubicin), JANSSEN-CILAG Pty Ltd., TGA, May 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2011-PI-02041-3









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