The European Medicines Agency (EMA) has recommended the withdrawal of marketing authorisation for olaratumab (Lartruvo) in the European Union/European Economic Area (EU/EEA).
The decision follows the publication of the full results of the ANNOUNCE study, which failed to show a clinical benefit with olaratumab plus doxorubicin in patients with advanced or metastatic soft tissue sarcoma.
The study did not meet its primary objective of prolonged overall survival in the overall population (stratified hazard ratio [HR] 1.05; median 20.4 for olaratumab plus doxorubicin versus 19.8 months for doxorubicin alone) or in the leiomyosarcoma sub-population (HR 0.95; median 21.6 months for olaratumab plus doxorubicin versus 21.9 months for placebo plus doxorubicin).
Additionally, no benefit was shown in progression-free survival in the overall population (HR 1.23; median 5.4 months for olaratumab plus doxorubicin versus 6.8 months for placebo plus doxorubicin).
In January 2019, when preliminary results of the ANNOUNCE study became available, the EMA recommended that no new patients should start treatment with olaratumab while the data were being reviewed. Having now assessed the full data from the study, the agency has concluded that the benefit of olaratumab in combination with doxorubicin is not confirmed.