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Lartruvo Fails Confirmatory Study, Promotion Suspended

January 23, 2019

Eli Lilly and Company has reported that the results of ANNOUNCE, the phase III study of Lartruvo (olaratumab) in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as compared to doxorubicin.

Lartruvo is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. This indication was approved under accelerated approval in 2016; according to the FDA label, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

The company reports that it is working with global regulators to determine the appropriate next steps; at this time, Lilly is suspending promotion of Lartruvo.

 

Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of Lartruvo [news release]. January 18, 2019. Available at: click here. Accessed January 19, 2019.