Regulator Perceptions in Cancer Evolving opinions about the oncology drug approval process

Introduction

The oncology therapy area is unlikely to be spared from the heightened conservatism currently sweeping the regulatory environment. This is evidenced by the increased scrutiny with which the FDA appraises accelerated approval applications, particularly in light of the 2005 withdrawal of AstraZeneca's Iressa.

Scope of this report

Examine the function and process of EU and US regulatory advisory committees and the dynamics of their relationship with the FDA or EU Commission.

Regulator perceptions on the evolution of endpoint designation and clinical trial design for oncology drugs.

Opinions on biomarker validation in the development of novel cancer treatments.

The impact of the increasingly more conservative regulatory environment on accelerated approvals in oncology.

Research and analysis highlights

The FDA's accelerated approval program is under intense scrutiny following the Vioxx debacle and the market withdrawal of AstraZeneca's Iressa. Developers need to be cognizant of the fact that seeking regulatory approval via this expedited route may be come increasingly more challenging.

The identification and validation of more robust and reliable surrogate endpoints will help streamline and expedite the drug development process, possibly even negating the need for cumbersome and slow-to-recruit post-marketing studies for drugs that have realized accelerated approval.

Regulators are enthusiastic about adaptive clinical trial designs that employ novel statistical approaches to help drive efficiencies in the oncology drug development process.

Key reasons to read this report

Gauge regulator opinion on aspects of pharmacovigilance as it relates to the oncology drug approval process.

Ascertain regulator receptiveness to innovations in oncology clinical trial design and endpoint designation.

Determine what other kinds of 'restructuring', in terms of legal and regulatory rules, would help drive efficiencies in oncology drug development.

Published: 8 November 2006

Format: PDF
Table of Contents
Price: $1,900.00 / GBP1,045.00