CancerConnect News: The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer. This follows review of the Phase 2 clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
About Fast Track Designation
Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market expeditiously.
About Pancreatic Ductal Adenocarcinoma and Connective Tissue Growth Factor
Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. According to the National Cancer Institute, in 2016, there were approximately 53,000 new cases of pancreatic cancer projected in the United States alone. Pancreatic cancer is aggressive and typically not diagnosed until it is often incurable. Most patients are diagnosed after the age of 45, and overall five-year survival is about 7%, due to many factors, including advanced stage at diagnosis and limited response to currently available therapies. Pancreatic cancers often exhibit extensive connective tissue stroma and elevated levels of Connective Tissue Growth Factor (CTGF). Cancer-stroma interactions affect cancer growth, angiogenesis, resistance to therapy and metastatic spread of tumor cells. CTGF is overexpressed in pancreatic cancer and facilitates progression and metastasis
Pamrevlumab (FG-3019) is a precision cancer medicine that targets and inhibits connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In pancreatic cancer CTGF is associated with cancer and growth of abnormal stromal cells and tumor cells. Pre clinical studies indicate that treatment with pamrevlumab in combination with chemotherapy may enhance the effectiveness of chemotherapy and improve survival.
In a comparative clinical trial, pamrevlumab in combination with gemcitabine and nab-paclitaxel chemotherapy was compared to chemotherapy alone for the treatment of patients with locally advanced pancreatic ductal adenocarcinoma who were considered inoperable.
Overall 7 of the 12 patients assigned to treatment with pamrevlumab became eligible to undergo surgical resection compared to only 1 of 11 treated with chemotherapy alone. The doctors reported that differences in overall survival between patients treated with and without pamrevlumab look encouraging and suggest that pamrevlumab has the potential to provide meaningful benefit for pancreatic cancer patients with locally advanced and/or metastatic disease.