Pfizer, Astellas clinch expanded approval for Xtandi in earlier line of prostate cancer

Pfiz­er and Astel­las on Thurs­day nabbed an ex­pand­ed ap­proval for Xtan­di (en­za­lu­tamide) to treat non-metasta­t­ic cas­tra­tion-sen­si­tive prostate can­cer with bio­chem­i­cal re­cur­rence at high risk for metas­ta­sis.

The ap­proval, which came five weeks ahead of its PDU­FA date, is based on Phase III re­sults from the com­pa­nies’ EM­BARK tri­al, which ex­am­ined Xtan­di plus le­upro­lide, place­bo plus le­upro­lide, and Xtan­di on its own in pa­tients with non-metasta­t­ic hor­mone-sen­si­tive prostate can­cer with high-risk BCR.  The tri­al en­rolled 1,068 pa­tients and met its pri­ma­ry end­point of a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in risk of metas­ta­sis or death com­pared to a place­bo plus le­upro­lide.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.