The European Commission has granted Lilly’s Lartruvo (orlaratumab) marketing authorisation for the first-line treatment of patients with advanced soft tissue sarcoma (STS).
The monoclonal antibody is the first of its kind to receive a licence for STS, and ended a four-decade drought for new frontline therapies in this area when it won FDA accelerated approval in October.
Awarded a conditional licence by European regulators, Lartruvo will be administered in combination with chemotherapy drug doxorubicin in previously untreated adults with advanced STS not eligible for curative surgery or radiotherapy.
The EC’s decision was based on phase II data from the JGDG trial, which showed the combination almost doubled survival, extending it to 26.5 months compared to 14.7 for doxorubicin alone.
Having awarded an accelerated approval, the EMA has requested additional data from the ongoing ANNOUNCE phase III study which is due to generate results in 2019. Until then, Lartruvo will be subject to an annual safety review by the CHMP.
Dr Sue Mahony, president of Lilly Oncology, said: “With this decision, olaratumab is now authorised for use in the EU, offering a new treatment option for soft tissue sarcoma patients in Europe.
“This news further reinforces Lilly’s ongoing commitment toward these types of rare diseases and the patients that are affected around the globe.”