INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) announced the U.S. FDA has granted approval of LARTRUVO, in combination with doxorubicin, for the treatment of adults 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. LARTRUVO's indication is approved under Accelerated Approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The company said its confirmatory Phase 3 trial, ANNOUNCE, is fully enrolled.
LARTRUVO is the first monoclonal antibody approved to treat soft tissue sarcoma. It also received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication.
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