Imaging Endpoints Supports FDA Approvals For Two New Cancer Treatments

On May 27, 2020 Imaging Endpoints reported that it has supported two additional U.S. Food and Drug Administration (FDA) approvals this month for new, life-saving therapies (Press release, Imaging Endpoints, MAY 27, 2020, View Source [SID1234558588]). The two New Drug Application (NDA) approvals, for two of the Company’s pharmaceutical company clients, included indications for adult patients with non-small cell lung cancer (NSCLC), adult and pediatric patients with thyroid cancer, and adult patients with advanced gastrointestinal stromal tumors (GIST).

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Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for these new cancer treatments. The large, global clinical trials that supported these approvals included complex imaging requirements, a double read paradigm with real-time reporting, and included imaging within the primary endpoint.

Imaging Endpoints’ robust processes are designed to meet or exceed industry standards. All inspections to date, including inspections in 2018, 2019 and 2020 by FDA and the European Medicines Agency (EMA), have resulted in zero observations, clearly demonstrating the Company’s leadership in quality and compliance.

Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: "We are honored to have supported the FDA approval of these two additional life-saving therapeutics as part of our relentless endeavor to Connect Imaging to the CureTM. Our rapid growth and success is the result of our dedication to provide industry-leading expertise, technologies and services through our amazing global team."