FDA OKs Use of Tool to Predict Patient Response to New Form of Cisplatin in Planned Phase 3 Study

FDA OKs Use of Tool to Predict Patient Response to New Form of Cisplatin in Planned Phase 3 Study
The U.S. Food and Drug Administration (FDA) has approved use of a device, called LiPlaCis DRP, that works to predict response to the next-generation investigational chemotherapy LiPlaCis in a planned Phase 3 clinical trial in people with metastatic breast cancer, Oncology Venture, the company developing both, reports. The FDA is also evaluating the company's request to use LiPlaCis in the pivotal trial, a necessary step in starting the study. Dialogue between Oncology Venture and the FDA is ongoing. LiPlaCis is primarily being developed as a potential treatment for people with metastatic breast cancer who failed to respond to previous lines of therapy. It is an encapsulated formulation of the chemotherapy cisplatin, designed to enable direct delivery to the tumor. The current formulation of cisplatin, Platinol, is effective in about 10% of patients and shows significant toxicity. LiPlaCis DRP (DRP stands for drug response predictor) is a device that includes 205 genes, and works to select patients whose cancer genetics indicate a high likelihood of responding to LiPlaCis. Determination is based on the patients’ messenger RNA —  produced from DNA in gene expression — that is collected in a pre-treatment biopsy. The device builds on a comparison of sensitive and resistant human cancer cell lines, while incorporating information about tumor biology and known clinical outcomes. “The F
Subscribe or to access all post and page content.

Leave a Comment

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.