Indian Authority Provides Marketing Clearance to APAC Biotech’s Apceden
APAC Biotech was granted a commercial license by India’s Central Drugs Standard Control Organization to market Apceden, a dendritic cell-based autologous immuno-oncology product for treating prostate, ovarian, colo-rectal and non-small cell lung carcinomas.
The drug is an autologous monocyte-derived mature dendritic cell containing a tumor antigen that can generate an effective immune response against the tumor.
In a 2011 clinical trial of patients with refractory solid tumor with multiple chemo failure, 28.9 percent of cases showed stability of the disease with good quality of life.
A retrospective study observed more than 200 days' of survival benefit compared to the control group.