Eli Lilly’s Soft-Tissue Cancer Drug Lartruvo Achieves Accelerated Approval

The FDA awarded Eli Lilly accelerated approval for its soft-tissue cancer therapy Lartruvo in combination with doxorubicin chemotherapies.

The product is indicated for the treatment of soft-tissue sarcoma when patients cannot use anthracycline chemotherapies or cannot be cured with either radiation or surgery, the FDA said, noting that this is the first therapy approved for initial treatment of STS in more than 40 years.

The FDA based the approval on a Phase 2 study of the therapy that showed Lartruvo with doxorubicin chemotherapies improved overall survival and disease progression. The accelerated approval requires that Eli Lilly provide post-market evidence of the drug’s safety and efficacy.