The Food and Drug Administration (FDA) has granted accelerated approval to Lartruvo (olaratumab; Eli Lilly) injection with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS).

Lartruvo is specifically for use in patients with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. The approval of Lartruvo, in combination with doxorubicin, marks the first FDA-approved front-line therapy for STS in over 40 years. 

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Lartruvo, a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, works by blocking PDGF receptors, which can aid in slowing or stopping tumor growth. STS tumors occur in the muscle, fat, blood vessels, nerves, tendons or the lining of the joints. This is the first monoclonal antibody to receive approval for the treatment of STS.

Patients who received Lartruvo + doxorubicin had a statistically significant improvement in median OS compared to patients who took doxorubicin alone (26.5 months vs. 14.7 months; hazard ratio [HR] 0.52, 95% CI: 0.34, 0.79; P<0.05). Also, the study met its endpoint for median PFS with 8.2 months for the Lartruvo + doxorubicin group vs. 4.4 months for the doxorubicin alone group (HR 0.74, 95% CI: 0.46, 1.19). 

ORR, defined as complete response (CR) plus partial response (PR), was also evaluated with an ORR of 18.2% (95% CI: 9.8, 29.6) (CR, 4.5%; PR, 13.6%) on the Lartruvo + doxorubicin group vs. 7.5% (95% CI: 2.5, 16.6) (CR, 1.5%; PR, 6%) on the doxorubicin only group.

The most common side effects of treatment with Lartruvo are nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy and headache.

Lartruvo will be available as a 10mg/mL solution in single-dose vials. 

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