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（纳斯达克：oncy）（tsx：onc）是一家领先的临床阶段公司，专注于肿瘤免疫治疗，在肿瘤学领域具有专业技术。今天宣布，公司与美国食品药品监督管理局（fda）进行了c型会议，并获得了富有成效的反馈，支持该公司计划在hr + / her2-转移性乳腺癌（mbc）中进行潜在的注册试验。fda支持进展自由生存作为研究的主要终点，全身生存作为重要的次要终点。公司拟建议的研究将招募失败激素治疗并接受了一线抗体药物结合物（adc）治疗的患者。