Eli Lilly's Lartruvo has received a conditional marketing approval by the European Commission to treat soft tissue sarcoma (STS).
Lartruvo (olaratumab) - the first monoclonal antibody to win regulatory clearance for treatment of the disease - can now be used alongside the chemotherapy doxorubicin in patients with advanced STS when surgery or radiotherapy is not suitable.
Forty to sixty percent of patients with STS will be in an advanced stage of the disease, and only half will live longer than five years under currently available treatment. This prognosis has not changed over the last forty years, highlighting the urgent need for new and more effective options.
EU clearance comes after data from a Phase II study in STS patients, who had not been previously treated with doxorubicin, showed a median survival gain of 11.8 month in those taking the combination versus those on the chemotherapy alone.
Patients treated with the Lartruvo/doxorubicin combo achieved 8.2 months of median PFS compared to 4.4 months on the doxorubicin-only arm, while the objective response rate was 18.2 percent versus 7.5 percent, respectively.
As part of a conditional marketing authorisation, Lilly will need to provide data from its ongoing Phase III study ANNOUNCE, which has fully enrolled with follow-up is underway. Until this data is available, the CHMP will review the benefits and risks of the drug annually to determine whether the conditional marketing authorisation can be maintained.
The drug was approved in the US for STS back in October.