FDA Approves Lartruvo for Soft Tissue Sarcoma

Written By:Stacy Simon

Editor's Note May 15, 2019:

Lartruvo is being pulled off the market for treatment of advanced soft tissue sarcoma because the larger phase 3 clinical trial did not show it helped patients live longer. Once the drug is withdrawn, no new patients will have access to it outside of ongoing clinical trials. People already taking Lartruvo should talk to their health care team. The drug's manufacturer, Eli Lilly and Company, is setting up a program to make sure current patients have access to Lartruvo with limited interruption even after it's taken off the market. These patients will have to consult with their health care team and be informed of the results of the new study and the risks of taking the drug.

The US Food and Drug Administration (FDA) has approved Lartruvo (olaratumab) for advanced soft tissue sarcoma. It’s for people with the disease who are not good candidates for radiation or surgery. The new drug is to be used in combination with the chemotherapy drug doxorubicin.

Soft tissue sarcomas are cancers that develop in muscles, fat, tendons, or other soft tissues anywhere in the body. There are not many treatment options available for this type of cancer; therefore, a new drug approval is a significant development.

Lartruvo is a monoclonal antibody, which is a manmade version of an immune system protein. It works by targeting a protein on cancer cells called PDGFR-alpha, which often helps these cells grow. Blocking this protein can help stop or slow tumor growth.

The FDA based its approval on a study of 133 people with more than 25 different subtypes of soft tissue sarcoma that had spread to other parts of the body. Some people in the study received Lartruvo and doxorubicin, and others received doxorubicin alone. The study looked at how long participants lived after treatment, how long tumors stopped growing after treatment, and how many participants saw their tumors shrink. All the results showed Lartruvo to be effective.

  • Participants who received both Lartruvo and doxorubicin lived for an average 26.5 months, compared to 14.7 months for those who received only doxorubicin.
  • Participants who received both Lartruvo and doxorubicin had a longer time when their tumors stopped growing after treatment compared with those who received only doxorubicin (8.2 months compared to 4.4 months).
  • More than 18% of participants who received both Lartruvo and doxorubicin saw their tumors shrink compared with 7.5% who received doxorubicin alone.

The FDA granted Lartruvo accelerated approval, priority review, breakthrough therapy status, and orphan product designation, all designed to speed up the approval process and to encourage development of new therapies for rare diseases.

The most common side effects of Lartruvo are nausea and vomiting, fatigue; low levels of white blood cells; muscle, bone, and abdominal pain; sores and swelling in the mucus membranes; hair loss; diarrhea; decreased appetite; nerve damage; and headache. Lartruvo can also cause an allergic-like reaction while getting the drug. Symptoms can include low blood pressure, fever, chills, and rash, but sometimes can be more serious. Lartruvo can harm an unborn baby if a woman takes it while she is pregnant.

Lartruvo is marketed by Eli Lilly and Company.

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