EMA has completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. The Agency is therefore recommending that the marketing authorisation of the medicine be revoked.
In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine. Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed. Regarding safety, the data did not show any new safety concerns.
Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines. At the time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported its authorisation. The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study.