Last reviewed: March 2019
Last updated: February  2019
06 Feb 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 European Medicines Agency (EMA) recommends that:

  • No new patients should start treatment with olaratumab

  • Consideration may be given to continuing olaratumab in patients currently being treated with the medicine if they appear to benefit from it.

Similar recommendations have been proposed by the US Food and Drug Administration.

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

In November 2016, olaratumab received conditional marketing authorisation approval (one of the EU’s early access routes for medicines that target serious, debilitating, life-threatening, or rare disease) for the treatment of advanced soft tissue sarcoma not amenable to curative treatment, in combination with doxorubicin. 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 marketing authorisation of olaratumab was, therefore, approved 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 compared with doxorubicin, respectively).

See Management: approach See Management: treatment algorithm

Original source of update



History and exam

Key diagnostic factors

  • mass
  • upper/lower gastrointestinal 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
  • lymphoedema
  • hx of exposure to chemical carcinogens

Diagnostic investigations

1st investigations to order

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

Investigations to consider

  • ultrasound of primary tumour
  • chest x-ray
  • positive emission tomography scan
  • endoscopy
  • biopsy for histology
  • FBC
  • urea
  • creatinine
  • LFTs
  • echocardiogram or multi-gated acquisition (MUGA) scan
  • genetic testing
Full details

Treatment algorithm


Authors VIEW ALL

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 reviewers VIEW 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.

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