FDA Approves Lartruvo for the Treatment of Soft Tissue Sarcoma

The FDA has approved Lilly’s Lartruvo (olaratumab injection), in combination with doxorubicin, for the treatment of soft tissue sarcoma (STS) in adults.

Lartruvo, a platelet-derived growth factor receptor alpha-blocking antibody, works by binding to PDGFR-α and preventing receptor activation. The drug is indicated for use in patients who have a histologic subtype for which an anthracycline-containing regimen is acceptable, and have not responded to curative treatment with radiotherapy or surgery.

The drug was given Accelerated Approval based on data from the phase 2 portion of the JGDG trial. Continued approval for the drug’s indication may be based upon verification and description of clinical benefit. Lilly is now moving forward with ANNOUNCE, a confirmatory phase 3 trial.

“Lartruvo represents an important step forward in soft tissue sarcoma treatment,” said William D. Tap, MD, principal investigator of the JGDG registration trial, in a press release. “We are pleased with this approval, which will provide patients with a treatment option that offers new hope in their battle against this difficult disease.”

Results from the JGDG trial showed that Lartruvo, in combination with doxorubicin, extended overall survival by 11.8 months (80%) compared with the standard of care, doxorubicin, in soft tissue sarcoma. The most common adverse effects associated with Lartruvo, in combination with doxorubicin, were nausea, fatigue, musculoskeletal pain, mucositis, vomiting, diarrhea, and headache.

Lartruvo is the first monoclonal antibody approved to treat STS and Lartruvo plus doxorubicin is the first FDA-approved front-line combination therapy for STS in 4 decades.