Eli Lilly gains accelerated approval from FDA for soft tissue sarcoma drug
pharmafile | October 20, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |Â Â Eli Lilly, FDA, US, soft tissue sarcomaÂ
Eli Lilly received the positive news that their drug, Lartruvo, has been granted accelerated approval for use in conjunction with FDA-approved chemotherapy doxorubicin for the treatment of soft tissue sarcoma. The treatment is approved for use in patients who cannot be cured via conventional treatment, such as with radiation and surgery, or in those who have a type of STS for which chemotherapeutic agent anthracycline is an appropriate treatment.
Soft tissue sarcoma is a disease that has multiple subtypes, meaning it is very difficult to diagnose and challenging to treat. There has been no first-line therapeutic treatment for STS that has improved overall survival for decades and there is therefore an urgent need for treatment. The progression-free survival rates primary endpoint was met in a recent clinical trial, with an improvement over standard treatment from 4.4 months to 8.2 months.
Speaking on the release of the news, Bert E. Thomas IV, PhD, MBA, CEO of the Sarcoma Foundation of America, said: “The entire sarcoma patient community is excited to have an innovative medicine approved for the treatment of advanced soft tissue sarcoma…We are confident that the approval of LARTRUVO may help these patients live longer.”
“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. “This continues our commitment to discovering new ways to treat cancer, including for people who have rare types of cancer.”
Ben Hargreaves
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