16 September 2016 - Positive opinion is the first global regulatory step towards approval for olaratumab.

Eli Lilly announced today that the EMA CHMP has issued a positive opinion recommending the granting of a conditional marketing authorization for olaratumab, in combination with doxorubicin, for the treatment of adults in the EU with advanced soft tissue sarcoma 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.

This is the first regulatory step in the world towards approval for olaratumab. 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.

Read Eli Lilly press release