- The Food and Drug Administration on Wednesday approved Eli Lilly’s Lartruvo (olaratumab) for first-line treatment of a subtype of advanced soft tissue sarcoma (STS), making it the first new front-line drug okayed for that indication in four decades.
- The agency approved the drug in combination with the long-standing chemotherapy doxorubicin based on Phase 2 results which showed an 11.8-month improvement in median overall survival compared to doxorubicin alone.
- Lilly has fully enrolled a confirmatory Phase 3 trial across several STS subtypes to meet the conditions of the FDA's accelerated approval.
The fast-tracked approval of Lartruvo keeps Lilly on schedule for the push it made to get the drug through review by the end of 2016.
The Indianapolis-based biopharma has an ambitious goal of winning approval for 20 new drugs between 2014 and 2023. Lartruvo’s green light puts them about one-third of the way toward that objective.
Latruvo is a monoclonal antibody which binds to the PDGFR-alpha receptor. The drug’s approval was based on data from a 133-patient Phase 2 study that showed longer life expectancy, slower tumor progression and greater likelihood of tumor shrinkage in patients who received Lartruvo and doxorubicin versus the chemotherapy alone.
Only patients who have a certain histologic subtype of STS are eligible to receive Latruvo, however.
“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in an October 19 statement. “This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago.”
Other companies are advancing their own soft tissue sarcoma drugs in later lines of treatment. In January, the Japanese pharmaceutical company Eisai won U.S. approval for its cancer drug Halaven (eribulin mseylate) in second line treatment of metastatic liposarcoma.
STS is a cancer that develops in certain body tissues, including muscle, fat, nerves and tendons. The National Cancer Institute anticipates that, among U.S. adults, there will be 12,310 new cases of the disease and nearly 5,000 deaths from it in 2016.