Last reviewed:October 2019
Last updated:February  2019
09 May 2019

No new patients should start treatment with olaratumab

Olaratumab combined with doxorubicin does not prolong the lives of patients with advanced or metastatic soft tissue sarcoma compared with doxorubicin alone, the phase III ANNOUNCE trial has found. While full study results are awaited, the US Food and Drugs Administration (FDA) recommends that:

  • Olaratumab should not be initiated in new patients outside of an investigational study

  • Patients who are currently receiving olaratumab should consult with their healthcare provider about whether to remain on the treatment.

Based on the available information, there are no safety concerns with the medicine.

In October 2016, the Food and Drug Administration granted olaratumab (in combination with doxorubicin) accelerated approval for the treatment of specific adult patients with soft tissue sarcoma not amenable to curative treatment. However, at the time of approval, data on the effects of the treatment were limited due to the small number of patients included in the main study supporting the application. The accelerated approval of olaratumab was, therefore, on the proviso that additional data from the phase III ANNOUNCE trial confirmed the efficacy and safety of the medicine. The study did not meet its primary efficacy objective of prolonging survival (HR: 1.05; median 20.4 vs. 19.7 months for olaratumab plus doxorubicin versus doxorubicin, respectively).

In April 2019, the European Medicines Agency (EMA) recommended that the marketing authorisation for olaratumab should be withdrawn.

See Management: approach

Original source of update



History and exam

Key diagnostic factors

  • mass
  • upper/lower GI bleed
  • rash
  • purplish macular-papular lesions
  • dysfunctional uterine bleeding
  • increased abdominal girth
  • hx of HIV infection
  • features of acute abdomen
  • neuropathic pain

Other diagnostic factors

  • weight loss
  • fatigue
  • anorexia
  • abdominal bloating, discomfort, pain
  • unilateral extremity swelling

Risk factors

  • genetically inherited syndromes
  • radiation
  • human herpesvirus-8 (HHV-8) infection
  • congenital disorders
  • lymphedema
  • hx of exposure to chemical carcinogens

Diagnostic investigations

1st investigations to order

  • CT scan of primary tumor
  • MRI of primary tumor
  • CT scan chest
  • HIV test
Full details

Investigations to consider

  • ultrasound of primary tumor
  • CXR
  • PET scan
  • endoscopy
  • biopsy for histology
  • CBC
  • BUN
  • creatinine
  • LFTs
  • echocardiogram or multigated acquisition (MUGA) scan
  • genetic testing
Full details

Treatment algorithm


Assistant Professor of Clinical Medicine

USC Norris Comprehensive Cancer Center

Los Angeles



JSH declares that he has no competing interests.


USC Norris Comprehensive Cancer Center

Los Angeles



SS declares that she has no competing interests.


Sarcoma Oncology Center

Santa Monica



SPC declares that he has no competing interests.

Dr Swati Sikaria, Dr James S. Hu, and Dr Sant P. Chawla would like to gratefully acknowledge Dr Jonathan C. Trent, Dr Saira Hassan, and Dr David Thomas, previous contributors to this monograph. JCT and SH each declare that they have no competing interests. DT has received research support from Pfizer, Amgen, and Novartis.

Peer reviewersVIEW ALL


Department of Surgical Sciences

Professor and Chairman

ENT Clinic

University of Udine




AF declares that he has no competing interests.

Professor of Musculoskeletal Pathology

Institute of Orthopaedics and Musculoskeletal Science

University College London




AF declares that she has no competing interests.

Medical Oncologist

Memorial Sloan-Kettering Cancer Center

New York



RM declares that he has no competing interests.

Use of this content is subject to our disclaimer