Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone.
While full results from the study are awaited, EMA is recommending that no new patients should start treatment with the medicine.
For patients currently being treated with Lartruvo, their doctor may consider continuing treatment with the medicine if they appear to benefit from it. It is estimated that around 1,000 patients are currently treated with Lartruvo in the EU.
Based on the information available so far, there are no new safety concerns with the medicine, with side effects reported with the combination being similar to those with doxorubicin alone.
Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is a lack of suitable medicines. At 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 authorisation. The medicine was therefore granted a marketing authorisation on condition that the company provides additional data from the ANNOUNCE study in order to confirm the efficacy and safety of the medicine.
Healthcare professionals will be informed in writing of the preliminary results of the study and the current treatment recommendations. EMA will communicate further as appropriate.
A new study showed that Lartruvo in combination with doxorubicin is not more effective at prolonging patients’ lives than doxorubicin alone. No new patients should start treatment with the medicine. If you are being treated with Lartruvo, you should discuss with your doctor whether to continue treatment with the medicine. There are no new safety concerns with the medicine.
