FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma
The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with soft tissue sarcoma (STS) who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.
“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “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.”
Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. Lartruvo works by blocking these receptors, which may help slow or stop tumor growth.
The safety and efficacy of Lartruvo were studied in a randomized clinical trial involving 133 patients with more than 25 different subtypes of metastatic STS. Patients received either Lartruvo with doxorubicin or doxorubicin alone. Compared to patients who received doxorubicin alone，patients who received Lartruvo with doxorubicin had a statistically significant improvement in the median overall survival(26.5 months vs. 14.7 months), the median progression-free survival(8.2 months vs. 4.4 months) and the overall response rate(8.2 % vs. 7.5%).
在一项纳入133例、涉及25种以上不同亚型转移性STS患者的随机临床试验中，评价了Lartruvo的安全性和有效性。患者接受Lartruvo+多柔比星或单纯多柔比星治疗。相较于只以多柔比星治疗的患者，接受Lartruvo+多柔比星治疗的患者其中位总生存期（26.5个月 vs. 14.7个月）、中位无进展生存期（8.2个月 vs. 4.4个月）和总应答率（18.2% vs. 7.5%）均有统计学意义显著改善。
Lartruvo has serious risks including infusion-related reactions and embryo-fetal harm. Infusion-related reactions include low blood pressure, fever, chills and rash. The most common side effects of treatment with Lartruvo are nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy and headache.
The FDA granted the Lartruvo application fast track designation, breakthrough therapy designation and priority review status. Lartruvo also received orphan drug designation. The FDA is approving Lartruvo under the agency’s accelerated approval program.
The sponsor is conducting a larger study, which is currently underway, to further explore the effectiveness of Lartruvo across the multiple subtypes of STS.
Lartruvo is marketed by Eli Lilly and Company based in Indianapolis, Indiana.