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April 2019, the European Medicines Agency (EMA) recommended that the marketing authorisation for olaratumab should be withdrawn.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: approachAssistant Professor of Clinical Medicine
USC Norris Comprehensive Cancer Center
Los Angeles
CA
JSH declares that he has no competing interests.
Fellow
USC Norris Comprehensive Cancer Center
Los Angeles
CA
SS declares that she has no competing interests.
Director
Sarcoma Oncology Center
Santa Monica
CA
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.
Director
Department of Surgical Sciences
Professor and Chairman
ENT Clinic
University of Udine
Udine
Italy
AF declares that he has no competing interests.
Professor of Musculoskeletal Pathology
Institute of Orthopaedics and Musculoskeletal Science
University College London
Stanmore
UK
AF declares that she has no competing interests.
Medical Oncologist
Memorial Sloan-Kettering Cancer Center
New York
NY
RM declares that he has no competing interests.
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