Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

On 25 August 2020 the FDA announced the availability of the draft guidance for industry.

The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS.

FDA’s current thinking regarding inclusion of patients with brain metastases in clinical trials is addressed in the guidance for industry Cancer Clinical Trial Eligibility Criteria: Brain Metastases.

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