The Indian FDA (CDSCO – Central Drugs Standard Control Organization) has granted a commercial license to APAC Biotech to market Apceden, a Dendritic cell-based autologous Immuno-oncology drug for prostate, ovarian, colo-rectal and non small cell lung carcinoma form of cancers.
Following a stringent review of the application submitted by the Indian biotechnology company, the Indian regulator had issued the commercial license (Form 46) to carry out a post marketing surveillance on statistically significant number of patients for each of the four cancer indications.
An allogeneic-cultured mesenchymal cells from Stempeutics dubbed as Stempeucel, an autologous-cultured adult osteoblast named as Ossoron, Regenerative Medical Services’ autologous-cultured adult chondrocyte named as Chondron were among other products to have also secured the marketing license parallel by the regulator.
A well-known oncologist by the name Dr. Ashok Vaid said: “The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India.
“The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies.”
According to APAC Biotech, the autologous monocyte-derived mature Dendritic cell Apceden when loaded with tumor antigen has the ability to produce a potent immune response against the tumor.