The regulator has granted AXAL (generic name axalimogene filolisbac) Special Protocol Assessment (SPA) status, something only a quarter of oncology drug applicants received in the ten years to 2013.
The trial, AIM2CERV, will start to enrol patients this summer. It will need to prove the drug’s efficacy, safety and benefit compared to cost to receive final marketing approval, but the SPA has made that route much more straightforward said the company.
“Collaborative discussions with the FDA led to a positive outcome with a SPA that clearly defines the clinical and regulatory pathway for the approval and commercialization of AXAL for the treatment of patients,” said Daniel O’Connor, Advaxis’s chief executive.
“Obtaining a SPA for the AIM2CERV Phase 3 protocol was our number one priority this year and it has now been achieved.”
Bradley Monk, Professor of Gynecologic Oncology at Creighton University School of Medicine at St. Joseph’s Hospital and Advavis’s cervical cancer adviser, added: “The AIM2CERV trial will be a critical step in demonstrating that AXAL can be successful as an immunotherapy, with the trial’s goal to cure more women and prevent disease recurrence.”
Cervical cancer is the third most common form of cancer in females and kills 4,100 women in the US annually.