Have you already been prescribed LARTRUVO + doxorubicin? For tips on preparing for your first infusion, click here.

Clinical trial results |
LARTRUVO may help you live longer

LARTRUVO in combination with doxorubicin (a type of chemotherapy) helped people live significantly longer than those who took doxorubicin alone.

In a study, Lartruvo helped people with STS live nearly twice as long

Lived nearly 2 times longer

In a study, people who were treated with LARTRUVO + doxorubicin lived nearly twice as long as those who were treated with doxorubicin alone.

Half of the patients who received LARTRUVO + doxorubicin (66 people) were still alive at 26.5 months compared to 14.7 months with doxorubicin alone (67 people). This is a measure of how well a treatment works, which is called median overall survivalMedian overall survival: A way to measure how well a cancer treatment works in a clinical trial. It is the amount of time from the start of treatment until exactly half of patients are still alive.X.

Patients receiving LARTRUVO + doxorubicin (66 people) lived without their cancer getting worse for 8.2 months versus 4.4 months with doxorubicin alone

Slows the progression of disease

Patients receiving LARTRUVO + doxorubicin (66 people) lived without their cancer getting worse for 8.2 months versus 4.4 months with doxorubicin alone (67 people).

In a study, Lartruvo helped people with STS live nearly twice as long

2 times as many people experienced tumor shrinkage

Twice as many people had their tumors shrink with LARTRUVO + doxorubicin (18.2% of 66 patients) than with doxorubicin alone (7.5% of 67 patients).

LARTRUVO may not work for everyone. Individual results from treatment may vary.

STUDY DETAILS

A clinical study included 133 people with more than 20 different subtypes of soft tissue sarcoma. They received either LARTRUVO with doxorubicin or doxorubicin alone.

The study assessed overall survival, which is how long people lived after starting treatment. The trial also measured the length of time that tumors didn’t grow, spread, or worsen after starting treatment (progression-free survival) and the proportion of people whose tumors had shrunk (objective response rate).

LARTRUVO was studied in many different subtypes. Specific clinical benefits for each subtype have not been established. Talk to your healthcare team if you have questions regarding your specific subtype. Ask your doctor if LARTRUVO + doxorubicin is right for you.

In the study, people were assigned to one of 2 groups that each received a different medication regimen:

Group 1: 66 people treated with LARTRUVO + doxorubicin (a type of chemotherapy)

Group 2: 67 people treated with doxorubicin alone

People in the study were eligible to receive treatment with anthracycline, such as the chemotherapy doxorubicin. People in the study were not eligible for curative treatment with surgery or radiation.

Select Important Safety Information

Infusion reactions related to injecting LARTRUVO have occurred. Most of these reactions happened during or after the first or second LARTRUVO infusion. Signs and symptoms of infusion reactions include flushing, shortness of breath, severe trouble breathing, or fever/chills. In severe cases, severe low blood pressure, anaphylactic shock (a severe, potentially life- threatening allergic reaction), or cardiac arrest (abrupt loss of heart function) may occur. Tell your doctor if you have any of these symptoms. Your healthcare team will monitor you for these side effects. In the case of a severe infusion reaction, your LARTRUVO treatment will have to be immediately and permanently stopped.

Indication and Important Safety Information
WHO IS LARTRUVO FOR?

LARTRUVO (olaratumab) is a prescription medicine used with a type of chemotherapy called doxorubicin to treat adult patients with soft tissue sarcoma (STS) for whom doxorubicin is appropriate and who cannot be cured with radiation or surgery.

There is an ongoing study to confirm how LARTRUVO works in combination with doxorubicin.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO
What is the most important information I should know about LARTRUVO?
  • Infusion reactions related to injecting LARTRUVO have occurred. Most of these reactions happened during or after the first or second LARTRUVO infusion. Signs and symptoms of infusion reactions include flushing, shortness of breath, severe trouble breathing, or fever/chills. In severe cases, severe low blood pressure, anaphylactic shock (a severe, potentially life-threatening allergic reaction), or cardiac arrest (abrupt loss of heart function) may occur. Tell your doctor if you have any of these symptoms. Your healthcare team will monitor you for these side effects. In the case of a severe infusion reaction, your LARTRUVO treatment will have to be immediately and permanently stopped.
  • LARTRUVO can harm your unborn baby. You should avoid getting pregnant, and use effective birth control while receiving LARTRUVO and for at least 3 months after stopping LARTRUVO.
What are the most common side effects of LARTRUVO?
  • The most common side effects reported in patients treated with LARTRUVO when given in combination with doxorubicin were nausea; tiredness or weakness; pain in the muscles, joints, and bones; sores and swelling of the mouth and digestive tract; hair loss; vomiting; diarrhea; decreased appetite; stomach pain; weakness, numbness, or pain in the hands and feet; and headache.
  • The most common changes to blood tests were low white blood cell count, low platelet count, high blood sugar, increased blood clotting time, low blood potassium level, and low blood phosphate level.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

What should I tell my doctor before receiving treatment with LARTRUVO?

Before you receive LARTRUVO, tell your doctor if you:

  • Are pregnant or may be pregnant. If you become pregnant during treatment, discuss this with your doctor.
  • Are breastfeeding: your doctor will tell you not to breastfeed during LARTRUVO treatment and for at least 3 months after stopping LARTRUVO.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications.

LARTRUVO is available by prescription only.

Please see full Prescribing Information for additional information about LARTRUVO.

OR CON ISI 12JAN2017