Bay­er, Ori­on win speedy ap­proval for prostate can­cer drug daro­lu­tamide

Three months ahead of sched­ule, Bay­er and Finnish part­ner Ori­on’s prostate can­cer drug daro­lu­tamide has been cleared for use by the US reg­u­la­tor un­der pri­or­i­ty re­view. The an­dro­gen re­cep­tor (AR) in­hibitor will be mar­ket­ed as Nube­qa, and it was ap­proved for pa­tients with cas­tra­tion-re­sis­tant prostate can­cer that has not spread to oth­er parts of the body (nm­CR­PC).

Prostate can­cer is the sec­ond most com­mon­ly di­ag­nosed ma­lig­nan­cy in men glob­al­ly, and treat­ment op­tions in­clude surgery, ra­di­a­tion treat­ment and ther­a­py us­ing hor­mone-re­cep­tor an­tag­o­nists. How­ev­er, in near­ly every case, the can­cer grows re­sis­tant to con­ven­tion­al hor­mone ther­a­py and can spread to oth­er parts of the body. Cas­tra­tion-re­sis­tant prostate can­cer (CR­PC) is an ad­vanced form of the dis­ease and is char­ac­ter­ized by per­sis­tent, high lev­el AR func­tion and re­sis­tance to con­ven­tion­al an­ti-an­dro­gens.

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