Oncolytics Biotech Inc T.ONC

RE:RE:RE:RE:RE:ONCY pelareorep demonstrates 69% ORR in pancreatic cancer

[Noteable]

The FDA’s Accelerated Approval (AA) pathway allows the use of surrogate endpoints, also called biomarkers, to evaluate the safety and efficacy of therapies for serious conditions with unmet needs 1. Surrogate endpoints are used when clinical outcomes might take a very long time to study or in cases where the clinical benefit of improving the surrogate endpoint, such as controlling blood pressure, is well understood. Clinical trials are needed to show that surrogate endpoints can be relied upon to predict, or correlate with, clinical benefit. Surrogate endpoints that have undergone this testing are called validated surrogate endpoints and these are accepted by the FDA as evidence of benefit 2. Products approved under the accelerated approval regulations require further adequate and well-controlled clinical trials to verify and describe clinical benefit. The FDA requires drug companies to conduct such clinical trials with due diligence 1.

The FDA’s Accelerated Approval pathway is designed to provide earlier access to promising new drugs for patients with serious conditions that lack adequate treatment options. The pathway is intended to expedite the development and review of drugs that demonstrate the potential to treat serious or life-threatening conditions and provide meaningful therapeutic benefit over existing treatments 1. Companies can apply for an accelerated approval after Phase 1 or 2 clinical trials have been completed and have shown promising results using a surrogate endpoint. The FDA will then review the data and determine whether there is enough evidence to support an accelerated approval 3.