The FDA has granted Aeterna Zentaris Special Protocol Assessment (SPA) for an upcoming phase III registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.
"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for AEZS-108 in endometrial cancer," said Juergen Engel, PhD, president and CEO of Aeterna Zentaris. "AEZS-108's innovative targeted approach could offer a new treatment option for women with endometrial cancer and provide the company with a significant market opportunity."
The trial will be an open-label, randomized, multi-center phase III study conducted in North America and Europe, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The trial will enroll approximately 500 patients and the primary efficacy endpoint is improvement in median overall survival.