FDA tags Bay­er's prostate can­cer drug for pri­or­i­ty re­view as drug­mak­er gears up against ri­vals

Two months af­ter Bay­er and its Finnish part­ner Ori­on re­port­ed pos­i­tive late-stage da­ta for its prostate can­cer drug daro­lu­tamide, the Ger­man drug­mak­er has con­vinced the FDA to grant pri­or­i­ty re­view on its NDA.

Like Pfiz­er’s Xtan­di and J&J’s Er­lea­da, daro­lu­tamide is a non-steroidal an­dro­gen re­cep­tor in­hibitor for prostate can­cer pa­tients whose dis­ease has not spread but con­tin­ues to grow de­spite low testos­terone lev­els. But un­like the more en­trenched drugs — both billed as po­ten­tial block­busters — Bay­er says its drug has “in­her­ent­ly dif­fer­ent phar­ma­co­ki­net­ics,” lead­ing to less CNS tox­i­c­i­ty and low­er risk for drug-drug in­ter­ac­tions.

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