'...The COMP considered that the response analysis and the improvement in survival in patients associated with therapeutic dose versus sub-therapeutic dose presented in the clinical data could be considered relevant to establish medical plausibility. Significant benefit was established based on an indirect comparison to the published AURELIA trial for bevacizumab. Populations were not matched to allow for indirect comparisons, but were considered similar. For the purpose of orphan designation the crude indirect comparison was considered sufficient to demonstrate a survival benefit associated with treatment.
The Committee agreed that the condition, ovarian cancer, is a distinct medical entity and meets the criteria for orphan designation.
The intention to treat the condition with the medicinal product containing ofranergene obadenovec was considered justified based on preliminary clinical data demonstrating that treatment improved survival in recurrent platinum-resistant patients.
The condition is chronically debilitating in particular due to pain, weight loss, ascites and vaginal bleeding, and life-threatening with approximately half of the patients surviving less
than five years.The condition was estimated to be affecting approximately 3 in 10,000 persons in the
European Union, at the time the application was made.
In addition, although satisfactory methods of treatment of the condition exist in the European Union, the sponsor has provided sufficient justification for the assumption that the medicinal product containing ofranergene obadenovec will be of significant benefit to those
affected by the condition. The sponsor has provided preliminary clinical data that demonstrate that treatment improved survival in recurrent platinum-resistant patients. An indirect comparison was conducted to show that the survival benefit compared favourably
with the survival observed with authorised products. The Committee considered that this constitutes a clinically relevant advantage.
A positive opinion for ofranergene obadenovec, for treatment of ovarian cancer, was adopted by consensus'
