India’s CDSCO grants APAC Biotech license for immuno-oncology drug Apceden

The Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority, has granted a commercial license to APAC Biotech for the marketing of Apceden, a Dendritic cell-based autologous immuno-oncology drug. This approval marks a significant advancement in the treatment of various cancer types, including prostate, ovarian, colorectal, and non-small cell lung carcinoma.

Pioneering Cancer Therapy Approved

Apceden, designed to harness the body’s immune system to fight cancer, represents a novel approach in oncology. Following a rigorous review process, CDSCO has issued a commercial license (Form 46) and mandated a post-marketing surveillance study to monitor its efficacy across a statistically significant number of patients for each approved cancer indication.

Other Innovations in Cell-based Therapies

Alongside Apceden, other cell-based therapies have also received approval. These include Stempeutics’ allogeneic-cultured mesenchymal cells, known as Stempeucel, Regenerative Medical Services’ autologous-cultured adult osteoblast called Ossoron, and an autologous-cultured adult chondrocyte named Chondron. These approvals underscore a growing interest and advancement in regenerative medicine within India.

Expert Opinions and Clinical Findings

Dr. Ashok Vaid, a prominent oncologist, commented on the evolution of cancer treatment, “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, Apceden works by utilizing autologous monocyte-derived mature Dendritic cells loaded with tumor antigen, which elicits a potent immune response against the tumor. This mechanism offers a promising new avenue for patients whose tumors are resistant to conventional treatments.

The Future of Cancer Treatment in India

The licensing of Apceden is a milestone in India’s medical landscape, highlighting the country’s role in pioneering advanced treatments for chronic diseases. This move could significantly impact the quality of life for cancer patients in India and potentially set a precedent for future therapies in the global market.