FDA Recommends Against Initiating Olaratumab in Patients With Advanced Soft Tissue Sarcoma

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FDA issued a statement recommending against the use of olaratumab in new patients with sarcoma following the release of negative results from the phase 3 ANNOUNCE trial.
FDA issued a statement recommending against the use of olaratumab in new patients with sarcoma following the release of negative results from the phase 3 ANNOUNCE trial.

The United States Food and Drug Administration (FDA) issued a statement on January 24, 2019, that the regimen of olaratumab, a monoclonal antibody directed against platelet-derived growth factor receptor A, in combination with doxorubicin should not be administered to patients with soft tissue sarcoma who have not yet received this treatment (unless they are enrolled in a clinical trial).1

In addition, the FDA recommended that patients currently receiving this regimen should discuss the potential risks and benefits of treatment continuation with their health care providers.

This statement was issued following an announcement of results from the phase 3 randomized, double-blind ANNOUNCE trial (ClinicalTrials.gov Identifier: NCT02451943), which compared olaratumab plus doxorubicin with doxorubicin alone and showed no overall survival benefit for the olaratumab-based regimen.2

On the basis of promising phase 2 results from the JDRG study (ClinicalTrials.gov Identifier: NCT01185964), the combination of olaratumab plus doxorubicin received accelerated approval from the FDA in October 2016 for the treatment of adult patients with soft tissue sarcoma who are not candidates for curative therapy.3 

However, results from the confirmatory phase 3 ANNOUNCE trial, which enrolled 460 patients with advanced, unresectable soft tissue sarcoma, showed no difference in median overall survival (OS) between the 2 treatment arms (20.4 months with olaratumab/doxorubicin and 19.7 months with doxorubicin plus placebo [HR, 1.05]).2

Similarly, a subgroup analysis of patients with leiomyosarcoma did not shown an OS benefit for combination therapy over doxorubicin plus placebo. Median PFS, a secondary objective of the study, was 5.4 months for patients in the olaratumab/doxorubicin arm and 6.8 months for those receiving doxorubicin plus placebo (HR, 1.23). No new safety signals were observed.

Based on these results, the European Medicines Agency (EMA) issued a recommendation on January 23, 2019, suggesting against the issuing of any new prescriptions for the olaratumab combination in patients with advanced soft tissue sarcoma.4


  1. FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma [press release]. United States Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm525878.htm. Published October 19, 2016. Updated January 24, 2019. Accessed January 28, 2019.
  2. Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of Lartruvo®. Eli Lilly and Company. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-results-phase-3-soft-tissue-sarcoma-study. Accessed January 28, 2019.
  3. Olaratumab (Lartruvo) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.
  4. No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life [press release]. European Medicines Agency. https://www.ema.europa.eu/documents/press-release/no-new-patients-should-start-treatment-lartruvo-after-study-shows-cancer-medicine-does-not-prolong_en.pdf. Published January 23, 2019. Accessed January 24, 2019.

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