27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System Metastases,” which, if finalised, would provide recommendations to sponsors designing clinical trials of drugs and biological products that are intended to support product labelling describing anti-tumour (preventing or inhibiting the formation or growth of tumours) activity in patients with central nervous system metastases from solid tumours originating outside the central nervous system.

The draft guidance, if finalised, would include recommendations for clinical trials of systemic anti-cancer drugs where patients with CNS metastases are included in the study population and for clinical trials conducted exclusively in patients with CNS metastases.

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