Lilly drug becomes EU's first approved MAb for advanced soft tissue sarcoma

US pharma major Eli Lilly (NYSE: LLY) has received conditional marketing authorization in Europe for Lartruvo (olaratumab injection, 10mg/mL) in combination with doxorubicin, for advanced soft tissue sarcoma (STS).

The conditional approval from the European Commission is granted for adults with STS for whom curative surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin.

Approval is based on data from the Phase II portion of the pivotal JGDG trial and followed a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which reviewed olaratumab under the EMA’s accelerated assessment program.