As­traZeneca/Mer­ck win EU ap­proval for front­line main­te­nance treat­ment of ovar­i­an can­cer, months af­ter FDA en­dorse­ment

As­traZeneca and Mer­ck’s PARP in­hibitor Lyn­parza has carved it­self a niche in Eu­rope.

Five months af­ter get­ting a speedy ap­proval from the US reg­u­la­tor for front­line main­te­nance treat­ment for BR­CA-mu­tat­ed ovar­i­an can­cer, the EU has fol­lowed suit, mark­ing the first PARP in­hibitor to win ap­proval for the in­di­ca­tion in the re­gion.

The ap­proval is based on re­sults from a 391-pa­tient study un­veiled in Oc­to­ber, which test­ed Lyn­parza against a place­bo in pa­tients giv­en plat­inum-based chemother­a­py. Da­ta showed that 40.7 months of fol­low-up showed the me­di­an time of pro­gres­sion for pa­tients treat­ed with Lyn­parza had not yet been reached ver­sus 13.8 months for those on place­bo.

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