Considerations For Pursuing Accelerated Approval In Oncology Indications

For many years, sponsors in the US have been able to apply for Accelerated Approval from regulators based on a surrogate endpoint. This approach is intended to speed products to market that treat serious or life-threatening conditions and that offer a benefit over current treatments. Similarly, in the EU, a conditional marketing authorization can be granted to drugs that fill an unmet need and treat rare or life-threatening diseases using less clinical data than would typically be required. Both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) require that the sponsor complete certain post-authorization study obligations. The pathway for Accelerated Approval is well established in these markets, and industry experts have gained considerable experience in guiding products through the process.