Advaxis Gets FDA Response For ODD

Advaxis has received the FDA letter denying the company’s request for Orphan Drug Designation (ODD) for the use of Adxs11-001 in invasive cervix cancer.

FDA stated that their market definition for invasive cervical cancer prevalence (including all those who had been cured) is over the 200,000 person cutoff.

Further, the applicability of Adxs11-01 for a precursor condition, cervical intraepithelial neoplasia (CIN) was considered by the ODD as an early manifestation of the disease. Moreover,There was no issue raised about efficacy.

Thomas Moore, Chairman and CEO, Advaxis, said: “When we announced this ODD filing, we said it was historically a 50% probability of getting approved. With an annual incidence of only 10,000 patients in the US diagnosed with invasive cervical cancer and a very poor prognosis if standard therapies fail, which they do for about half these patients, this appeared to be just what Orphan Drug was designed to encourage. The FDA Office of Orphan Products Development was very cooperative with us but we are naturally disappointed.

We have pending study activity in cervical cancer in collaboration with NCI and plan to conduct at least one additional off-shore study. Our Phase I results showed great promise. We will likely seek another regulatory route for this indication, Fast Track designation, for which we can apply in the near term. If approved, Fast Track provides similar advantages in regulatory acceleration, but provides no market exclusivity or the possibility of grant support from FDA, he added.