FDA grants AXAL fast track designation to treat cervical cancer
The FDA granted fast track designation to axalimogene filolisbac for the adjuvant treatment of high-risk locally advanced cervical cancer.
The investigation of axalimogene filolisbac (Advaxis) — a targeted immunotherapy also known as AXAL that attacks HPV–associated cancers — will be conducted in accordance with the special protocol assessment (SPA) recently granted by the FDA. The therapy works by altering a live strain of Listeria monocytogenes bacteria to generate T cells directed against the specific cancer antigen and neutralizing factors that protect the tumor microenvironment and contribute to tumor growth.
“This fast track designation for AXAL comes on the heels of the SPA agreement and underscores the collaborative efforts of Advaxis and the FDA in expediting a medically significant clinical program,” Daniel J. O'Connor, president and CEO of Advaxis, said in a press release. “This designation brings us one step closer to achieving our goal with the AIM2CERV trial, which aims to extend disease-free survival for this serious and life-threatening condition and prevent disease recurrence.”
Results of a phase 2 study of patients with recurrent/refractory cervical cancer demonstrated axalimogene filolisbac alone or in combination with chemotherapy prolonged survival, induced objective tumor responses and had manageable safety profile.
Axalimogene filolisbac also is under investigations in clinical trials for head and neck cancer and anal cancer.
The FDA previously granted axalimogene filolisbac orphan drug designation to treat invasive cervical cancer in 2014.