FDA, CancerLinQ to Track Real-World Targeted Therapy Use, Starting With Melanoma Drugs

Source: Genome Web, June 2017

CHICAGO (GenomeWeb) – The American Society for Clinical Oncology announced this week that it has added two new long-term partners to its big-data initiative CancerLinQ, one of which is the US Food and Drug Administration.

Under the new collaboration, FDA plans to use CancerLinQ’s repository of real-world evidence on patient treatment and outcomes to track how genomically targeted drugs and newer immunotherapies are used in clinical practice, comparing their impact to what has been seen in clinical trials, and tracing their use by physicians either according to, or in spite of, their labelling information.

The FDA’s Sean Khozin said at the ASCO annual meeting here this weekend that the agency is beginning the effort with a study of melanoma, in many ways a poster child for the rapid implementation of precision medicine, with a number of molecularly targeted drugs and immunotherapies having been rapidly incorporated into standard practice over the last several years.

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