Indian regulator approves the first autologous dendritic cell-based immuno-oncology product

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by India’s Central Drugs Standard Control Organization (CDSCO) to market product, Apcedene, a dendritic cell-based autologous Immuno-oncology product for four cancer indications namely prostate, ovarian, colorectal and non -small cell lung carcinoma.

The Indian authority, after their stringent review of the application, has issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely Stempeucel, an allogeneic-cultured mesenchymal cells from Stempeutics and Ossoron, an autologous-cultured adult osteoblast and Chondron, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.