FDA approves Lilly anti-cancer drug Lartruvo in combination with doxorubicin for first-line treatment of soft tissue sarcoma (STS)
October 26, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The US pharmaceutical giant Eli Lilly's anti-cancer pipeline has recently received good news in US regulation. The US Food and Drug Administration (FDA) has accelerated the approval of the new anti-cancer drug Lartruvo (olaratumab injection, 10mg/mL) combined with doxorubicin. (Doxorubicin) is a histological subtype suitable for adult patients with soft tissue sarcoma (STS) who are suitable for an anthracycline-containing regimen and are not suitable for radiotherapy or surgical resection.
The approval has made the Lartruvo+Doxorubicin regimen the first first-line treatment approved by the FDA for soft tissue sarcoma (STS) over the past 40 years, marking an important step in the clinical treatment of advanced STS. In clinical trials, Lartruvo in combination with doxorubicin increased STS overall survival by 11.8 months compared with doxorubicin monotherapy.
Soft tissue sarcoma (STS) is a general term for a large class of malignant tumors that occur in systemic soft tissues (fat, muscle, nerves, fibrous tissue, blood vessels). It is very complex and has multiple subtypes, making it difficult to diagnose and treat. There has been no progress in the first-line treatment of advanced STS overall survival (OS) in recent decades. According to the American Association for Cancer Research, in 2015, only 12,000 new cases of STS were diagnosed in the United States, and about 5,000 deaths. Therefore, there is a huge medical need in the field that is far from being met.
Lartruvo is a human platelet-derived growth factor receptor (PDGFRα) antagonist, the first monoclonal antibody drug approved by the FDA for the treatment of STS. Previously, the FDA had granted the drug a fast lane status, orphan drug status, breakthrough drug qualification, and priority review. In the EU, olaratumab received positive comments from the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) in the middle of last month, which also means that olaratumab is likely to be approved for listing in Europe by the end of this year.
Lartruvo's approval is based on data from a key Phase II JGDG study. The study was an open-label, randomized study of 133 cases of histological subtypes in adult patients with soft tissue sarcoma (STS) suitable for an anthracycline-containing regimen and not suitable for radiotherapy or surgical resection. Lartruvo + doxorubicin chemotherapy Combination therapy was compared with doxorubicin chemotherapy monotherapy. The data showed a median overall survival of 11.8 months in the Lartruvo + doxorubicin combination group compared with the doxorubicin monotherapy group, with statistically significant differences (median OS: 26.5 months vs 14.7 months, p<0.05). In addition, median progression-free survival was significantly increased by 4.4 months in the Lartruvo + doxorubicin combination group (median PFS: 8.2 months vs 4.4 months). At the time of data analysis, the total remission rate (ORR) was 18.2% in the Lartruvo + doxorubicin combination group, 39 cases (59%) died, and the ORR was 7.5% and 52 cases (78%) died in the doxorubicin monotherapy group.
Olaratumab is a human IgG1 monoclonal antibody designed to disrupt the PDGFRα signaling pathway on tumor cells and cells in the tumor microenvironment. The drug exerts anti-tumor activity by directly targeting tumor cells and surrounding cells that support tumor growth around the tumor. Currently, a phase III clinical trial of olaratumab combined with doxorubicin chemotherapy for advanced soft tissue sarcoma has been completed. Lilly will convert accelerated approval to full approval based on data from this Phase III study.
It is worth mentioning that in January this year, the FDA approved the new anticancer drug Halaven (Erebrin mesylate) developed by Eisai to treat advanced or metastatic liposarcoma. In May of this year, Halaven was approved by the European Union for the treatment of unresectable liposarcoma, a subtype of soft tissue sarcoma.
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