Eli Lilly's Lartruvo has been approved by the US Food and Drug Administration to treat soft tissue sarcoma.
Lartruvo (olaratumab) is a monoclonal antibody recommended for conditional approval for use alongside the chemotherapy doxorubicin in patients with advanced soft tissue sarcoma (STS) for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin.
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.
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 wight the Lartruvo/doxorubicin combination 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.
"The entire sarcoma patient community is excited to have an innovative medicine approved for the treatment of advanced soft tissue sarcoma," said Bert E. Thomas IV, chief executive of the Sarcoma Foundation of America. "We are confident that the approval of Lartruvo may help these patients live longer."
However, as Lilly's drug has been granted accelerated clearance, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory Phase III trial, which is already fully enrolled.
Lartruvo is also close to a green light across the pond, where the European Medicines Agency's Committee for Medicinal Products for Human Use recently voted in favour of its approval.