EU approves Lartruvo (olaratumab) to treat soft tissue sarcoma.- Eli Lilly
The European Commission has granted an accelerated approval to olaratumab (Lartruvo) in combination with doxorubicin as a frontline therapy for patients with advanced soft tissue sarcoma, making it the first new therapy for this indication in over 40 years.
The decision, which was preceded by a positive opinion from the Committee for Medicinal Products for Human Use, was based on findings from the phase II JGDG study, which showed an 11.8-month improvement in overall survival (OS) with the PDGFR alpha antagonist versus doxorubicin alone. The median OS was 26.5 months with the combination versus 14.7 months with doxorubicin alone (HR, 0.463; 95% CI, 0.301-0.710, P = .0003)
Comment: As part of the accelerated approval program, Lilly will be required to provide results from the ongoing phase III ANNOUNCE trial to support a continued authorization. This study is comparing the olaratumab/doxorubicin combination with doxorubicin alone (NCT02451943).
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