Eli Lilly and Company announced that FDA has granted approval of LARTRUV (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (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.
LARTRUVO’s indication is approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for STS in four decades. The confirmatory Phase 3 trial, ANNOUNCE, is fully enrolled, said Lilly.
“LARTRUVO represents an important step forward in soft tissue sarcoma treatment,” said William D. Tap, M.D., chief of the sarcoma medical oncology services at Memorial Sloan Kettering Cancer Center in New York and the principal investigator of the JGDG registration trial. “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.”, he added.
Soft tissue sarcoma is a complex disease with multiple subtypes, making it hard to diagnose and difficult to treat. For decades, there have been no first-line therapeutic advancements for STS that have improved overall survival (OS). According to the American Cancer Society, in 2015, there were an estimated 12,000 new STS cases diagnosed and nearly 5,000 deaths in the U.S. alone, representing an unmet medical need.
LARTRUVO is the first monoclonal antibody approved to treat STS. It also received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication, and was reviewed and approved under the FDA’s Accelerated Approval program. This program allows for earlier approval of drugs that treat serious conditions and that fill an unmet medical need, explained the company.
“The approval of LARTRUVO is based on an encouraging and positive study for patients, and represents progress in soft tissue sarcoma treatment. For the first time in four decades, we now have a combination regimen – LARTRUVO and doxorubicin – that offers progress over doxorubicin alone in the front-line setting, by improving overall survival for people with soft tissue sarcoma,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology and added: “This continues our commitment to discovering new ways to treat cancer, including for people who have rare types of cancer.”
“The entire sarcoma patient community is excited to have an innovative medicine approved for the treatment of advanced soft tissue sarcoma,” said Bert E. Thomas IV, PhD, MBA, CEO of the Sarcoma Foundation of America. “We are confident that the approval of LARTRUVO may help these patients live longer.”