Frustrations with AstraZeneca Immunotherapy Clinical Trial Design—FDA ODAC Unanimously Vote: Revamp Perioperative Lung Cancer Studies

While not a household name, the&nbsp;Oncologic Drugs Advisory Committee&nbsp;(ODAC) wields tremendous clout in the world of cancer care. Consisting of members from academic and clinical oncology biostatistics, the general public, and the pharmaceutical industry, ODAC receives requests for the technical and clinical evaluation of new drugs by the Food and Drug Administration (FDA), a critically important role vetting novel therapies.&nbsp;While the committee formulates and delivers non-binding recommendations to both the Center for Drug for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), divisions of America&rsquo;s food and drug regulator concerning the advisability of approving novel medications targeting cancer, those decisions aren&rsquo;t taken lightly and yesterday&rsquo;s verdict was serious.&nbsp;During yesterday&rsquo;s meeting,&nbsp;the committee&rsquo;s unanimous vote signals to the FDA to revamp perioperative clinical trial designs when concerning resectable, non-small cell lung cancer (NSCLC) patients, including an assessment of the contribution of each treatment phase.&nbsp;What is the net result of this decision yesterday should the FDA operationalize?&nbsp;It is a new requirement imposed on the industry involving combinations regimen at least with lung cancer, meaning not only that clinical trials will likely become more complicated, but also take more time and cost more money. The concern by the committee centers on the overtreatment of highly vulnerable, often elderly patients, should the combined regimen offer less than a compelling benefit, plus a high risk for safety concerns, and the potential for overtreatment-driven suffering.&nbsp;
See the FDA ODAC meeting briefing documentation.