FDA grants Fast Track status to MyVax
MyVax personalised immunotherapy produced by California, US-based Genitope has received a Fast Track designation from the US Food & Drug Administration (FDA) for the treatment of follicular non-Hodgkin's Lymphoma (fNHL).
MyVax personalised immunotherapy produced by California, US-based Genitope has received a Fast Track designation from the US Food & Drug Administration (FDA) for the treatment of follicular non-Hodgkin's Lymphoma (fNHL).
Fast Track designation is granted by the FDA to products that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.
MyVax is a patient-specific active immunotherapy based on the unique genetic makeup of a patient's tumour and is designed to activate the patient's immune system to identify and attack cancer cells.
"Securing Fast Track designation for MyVax personalised immunotherapy in advance of the Phase 3 study interim analysis this summer is especially meaningful and puts us one step further down our pathway toward commercialisation," said Dan Denney, ceo of Genitope Corporation. "We welcome this designation, as we execute against our commercialisation plan, which includes the build-out of our manufacturing facility, adding senior management and developing our product pipeline through a robust clinical program."