11 April 2018 - - The US Food and Drug Administration has accepted for filing with priority review Needham, Massachusetts-based cancer treatment developer Verastem, Inc.'s (NASDAQ: VSTM) new drug application for its lead product candidate duvelisib, the company said.
Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase -delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells.
Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma.
The FDA target action date is October 5, 2018.
Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma, and is being investigated in combination with other agents through investigator-sponsored studies.
Verastem is focused on discovering and developing drugs to improve outcomes for patients with cancer. The company's product candidates seek to treat cancer by modulating the local tumor microenvironment, enhancing anti-tumor immunity, and reducing cancer stem cells.