What is Lartruvo - Olaratumab used for and what is it used for?
Lartruvo is an anticancer medicine used to treat adult patients with advanced soft tissue sarcoma, a type of cancer that affects the soft supporting tissues of the body, such as muscles, blood vessels and adipose tissue. Lartruvo is used in combination with doxorubicin (another anticancer medicine) in patients who cannot undergo surgery or radiation therapy (radiation treatment) and who have not been previously treated with doxorubicin.
Because the number of patients with soft tissue sarcoma is low, the disease is considered "rare" and Lartruvo was qualified as an "orphan medicine" (a medicine used in rare diseases) on 12 February 2015.
How is Lartruvo - Olaratumab used?
The root can only be obtained with a prescription. Therapy should be started and supervised by a doctor who is experienced in treating cancer.
Lartruvo is available as a solution for infusion (drip) in a vein. During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained personnel and emergency resuscitation equipment should be available.
The recommended dose of Lartruvo is 15 mg per kilogram of body weight, given twice over a period of three weeks, on days 1 and 8. These three-week cycles should be repeated until the disease worsens or the side effects do not become unacceptable. Lartruvo is given in combination with doxorubicin up to a maximum of 8 treatment cycles, followed by Lartruvo alone in patients whose disease has not deteriorated. Doxorubicin is administered on day 1 of each cycle, after the infusion of Lartruvo.
For more information, see the package leaflet.
How does Lartruvo - Olaratumab work?
The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) designed to recognize and bind to a protein called "platelet-derived growth factor receptor-α" (PDGFRα). This protein is often found on the surface of cells where it plays a role in regulating cell multiplication. In tumors such as soft tissue sarcoma, this protein is present at high levels or is overactive, which causes the cells to become cancerous. By attaching to PDGFRα on sarcoma cells, Lartruvo should block its activity, thereby slowing tumor growth.
What benefit has Lartruvo - Olaratumab shown during the studies?
Lartruvo was examined in a main study involving 133 adults with advanced soft-tissue sarcoma who could not undergo surgery or radiotherapy and who had not been previously treated with anthracycline (a group of anticancer medicines that includes doxorubicin ). The study showed that Lartruvo in combination with doxorubicin was more effective than doxorubicin alone in prolonging the period in which patients live without their disease getting worse (progression-free survival). Patients treated with Lartruvo plus doxorubicin lived on average 6.6 months without the disease getting worse, compared to 4.1 months of those treated with doxorubicin alone. Furthermore, patients treated with the combination of Lartruvo plus doxorubicin experienced on the whole almost double the number of patients treated with doxorubicin (26.5 compared to 14.7 months, respectively).
What are the risks associated with Lartruvo - Olaratumab?
The most common side effects of Lartruvo (which may affect more than 1 in 10 people) are nausea, musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and mucositis (inflammation of the moist surfaces of the organism that most commonly affects the mouth and throat). The most frequent side effects that led to cessation of treatment were infusion-related reactions (allergic reactions that can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis. The most serious side effects were neutropenia and musculoskeletal pain.
For the full list of restrictions and all side effects reported with Lartruvo, see the package leaflet.
Why has Lartruvo - Olaratumab been approved?
Data from the main study show that Lartruvo in combination with doxorubicin improves both progression-free and overall survival of patients with advanced soft-tissue sarcoma. However, due to the small number of patients included in the main study, the company that markets the medicine will have to provide additional data. Regarding the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of undesirable effects; however, due to the benefits of the treatment, side effects were considered tolerable and manageable.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Lartruvo has obtained a "conditional approval". This means that further information on the medicine, which the company is required to provide, will be available in the future. Every year the European Medicines Agency will review the new information available and this summary will be updated accordingly.
What information is still awaited for Lartruvo?
Since a conditional approval has been issued for Lartruvo, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
What measures are being taken to ensure the safe and effective use of Lartruvo - Olaratumab?
Recommendations and precautions to be followed by healthcare professionals and patients so that Lartruvo is used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Lartruvo - Olaratumab
For the full version of the EPAR and the summary of the Lartruvo risk management plan, see the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Lartruvo therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products related to Lartruvo is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
