Eli Lilly and Company has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the granting of a conditional marketing authorization for olaratumab, in combination with doxorubicin, for adults in the European Union (EU) with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin. The CHMP reviewed olaratumab under EMA’s accelerated assessment program. If approved, olaratumab will be marketed under the trade name Lartruvo.

The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing authorization in the EU. The commission usually makes a decision on marketing authorization within two to three months of the CHMP issuing its recommendation.

This will be Lilly’s first conditional approval in the EU. As part of a conditional marketing authorization, Lilly will need to provide results from an ongoing Phase III study. The EMA previously granted orphan drug designation to olaratumab for treating soft tissue sarcoma in the EU.

The US Food and Drug Administration recently granted Lilly priority review status for olaratumab. Lilly also has received additional designations for olaratumab from the FDA for this indication, including breakthrough therapy, fast track, and orphan drug designation.

Source: Eli Lilly and Company