Oncolytics Biotech Advances Breast Cancer Trial With FDA Support
Oncolytics Biotech Advances Breast Cancer Trial With FDA Support
Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology, today announced that the Company received productive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint. The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.
oncolytics biotech公司（納斯達克：oncy）（tsx：onc）是一家領先的臨床階段公司，專注於腫瘤免疫治療，在腫瘤學領域具有專業技術。今天宣佈，公司與美國食品藥品監督管理局（fda）進行了c型會議，並獲得了富有成效的反饋，支持該公司計劃在hr + / her2-轉移性乳腺癌（mbc）中進行潛在的註冊試驗。fda支持進展自由生存作爲研究的主要終點，全身生存作爲重要的次要終點。公司擬建議的研究將招募失敗激素治療並接受了一線抗體藥物結合物（adc）治療的患者。
譯文內容由第三人軟體翻譯。