Imaging Endpoints announced today that it has supported another U.S. Food and Drug Administration (FDA) approval for a new, life-saving therapy

Imaging Endpoints announced today that it has supported another U.S. Food and Drug Administration (FDA) approval for a new, life-saving therapy. The New Drug Application (NDA) was granted accelerated approval, for the Company’s pharmaceutical client, and is indicated for relapsed or refractory mantle cell lymphoma.

Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for this novel cancer treatment. The large, on-going global clinical trial that supports this approval includes a double read paradigm with real-time reporting and a primary endpoint of objective response rate (ORR) per the Lugano Classification as assessed by Imaging Endpoints.

IE’s imaging CRO experience spans hundreds of successful trials across all phases of development, including some of the most high-profile, global registration trials in the industry. This is the third FDA approval that IE has supported in the last 3 months; IE expects that it may support a significant percentage of all oncology new drug approvals at FDA in 2020.

Imaging Endpoints is based in Scottsdale, Ariz., with an East Coast office in Waltham, Mass. IE is an affiliate of HonorHealth, one of the largest healthcare systems nationally, and an affiliate of Southwest Medical Imaging, Ltd. (SMIL/RadPharm), part of the largest private radiology group in the U.S.

For more information, contact Ashley Rusing at arusing@imagingendpoints.com or 480.605.1025.