CDSCO approves first autologous dendritic cell-based immuno-oncology product

APAC Biotech was granted with a commercial license by CDSCO to market its product, APCEDEN, a dendritic cell-based autologous immuno-oncology product for four cancer indications

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New Delhi: Indian biotechnology company, APAC Biotech, was granted with a commercial license by Central Drugs Standard Control Organization (CDSCO), the Indian FDA, to market its product, APCEDEN, a dendritic cell-based autologous immuno-oncology product for four cancer indications namely Prostate, Ovarian, Colo-rectal and Non-Small Cell Lung carcinoma.

The company says that the Indian Food and Drug Administration authorities, after their stringent review of the application, have 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, 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.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor.