FDA drafts rec­om­men­da­tions for study­ing can­cer drugs in pa­tients with CNS metas­tases

The FDA on Wednes­day is­sued draft guid­ance pro­vid­ing rec­om­men­da­tions to drug­mak­ers on eval­u­at­ing can­cer drugs in pa­tients with cen­tral ner­vous sys­tem (CNS) metas­tases. FDA says the guid­ance is meant to in­form clin­i­cal tri­al de­signs to sup­port prod­uct la­bel­ing that de­scribes an­ti­tu­mor ac­tiv­i­ty of drugs or bi­o­log­ics in pa­tients with CNS metas­tases from sol­id tu­mors orig­i­nat­ing in oth­er parts of the body.

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