EMA Recommends No New Patients Should Start Treatment with Lartruvo

Pharmaceutical Technology Editors

The European Medicines Agency has recommended that no new patients should start treatment with Lartruvo (olaratumab).

The European Medicines Agency has recommended that no new patients should start treatment with Lartruvo (olaratumab) after the preliminary results of the ANNOUNCE study have shown that it does not prolong life.

This recommendation has been released by the agency while it awaits the full results of the clinical study, evaluating Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma. Preliminary results from the study have shown that the combination therapy is not more effective at prolonging patients’ lives than treatment with doxorubicin alone.

For any patients who are currently receiving treatment with Lartruvo, consideration may be taken by the doctor for continuation of treatment, depending upon whether or not the patient is experiencing beneficial results. It is estimated that there are currently approximately 1000 patients being treated with Lartruvo in the European Union.

Lartruvo had received a conditional marketing authorization in November 2016 with the proviso that more substantial data be provided from the ANNOUNCE study in order to confirm the efficacy and safety of the medicine.

There are no safety concerns with the therapy based on the information that is available so far and healthcare professionals will be informed in writing of the results of the ANNOUNCE study and current treatment recommendations. Further notification to healthcare professionals will be made by EMA when necessary and appropriate.

Source: EMA