Watch out Tesaro, As­traZeneca and Mer­ck get FDA OK for broad use of Lyn­parza

Sean Bo­hen, As­traZeneca

As­traZeneca and its new Big Phar­ma part­ner Mer­ck have picked up the FDA’s ap­proval for the broad use of Lyn­parza, which will put it di­rect­ly in the mar­ket­ing path be­ing blazed by Tesaro.

Like Tesaro’s Ze­ju­la, Lyn­parza (ola­parib) can now be used as a main­te­nance ther­a­py for re­cur­rent ovar­i­an can­cer, re­gard­less of BR­CA mu­ta­tion sta­tus. And reg­u­la­tors al­so OK’d an eas­i­er dos­ing reg­i­men, with two tablets twice a day in­stead of eight cap­sules dai­ly.

Lyn­parza was orig­i­nal­ly re­strict­ed to a group of pa­tients who had failed mul­ti­ple ther­a­pies.

The broad ap­proval marks an­oth­er key ad­vance for As­traZeneca, which sold co-de­vel­op­ment and co-com­mer­cial­iza­tion rights to Mer­ck a few weeks ago for $1.6 bil­lion up­front. As­traZeneca has been mar­ket­ing off a va­ri­ety of as­sets over the last two years as it looks to en­gi­neer block­buster gains in on­col­o­gy.

The FDA’s ex­pand­ed la­bel in­cludes da­ta from the Phase III SO­LO-2 study, where pro­gres­sion-free sur­vival was 19.1 months on ola­parib vs. 5.5 months on place­bo, notes Jef­feries Eun Yang.

Yang adds that now that three PARPs are an­gling for mar­ket share — in­clud­ing Clo­vis drug Rubra­ca — the much buzzed about pos­si­bil­i­ty of a buy­out for Tesaro has di­min­ished con­sid­er­ably.

Tesaro shares $TSRO slid 3.5% Thurs­day af­ter­noon.

Lyn­parza was the first PARP to hit the mar­ket, and As­traZeneca fol­lowed up on the ac­cel­er­at­ed OK with more stud­ies demon­strat­ing its ef­fec­tive­ness in ovar­i­an can­cer. This drug has proven to be a key part of As­traZeneca’s case that it can make a come­back with its on­col­o­gy port­fo­lio — a case that took a nasty hit with the re­cent first-round flop for its com­bo of Imfinzi and the CT­LA-4 drug treme­li­mum­ab.

Mer­ck paid hand­some­ly to part­ner on this drug, which it will now take in­to its own com­bo stud­ies with its PD-1 star Keytru­da while As­traZeneca fol­lows up with Imfinzi. Ac­cord­ing to a sto­ry from Reuters, As­traZeneca and Mer­ck are lin­ing up an ap­pli­ca­tion on breast can­cer, with stud­ies un­der­way on prostate and pan­cre­at­ic can­cer.

As­traZeneca CMO Sean Bo­hen said:

Physi­cians have al­most three years of clin­i­cal ex­pe­ri­ence with Lyn­parza on the mar­ket and we are now pleased to bring this im­por­tant med­i­cine, in a new tablet for­mu­la­tion, to a broad­er group of women. To­day’s ap­provals val­i­date more than 10 years of ded­i­cat­ed re­search be­hind Lyn­parza, the world’s first PARP in­hibitor, which now pro­vides on­col­o­gists with the greater flex­i­bil­i­ty for use in terms of treat­ment set­tings. It builds on our re­cent­ly-an­nounced col­lab­o­ra­tion with Mer­ck, which aims to fur­ther in­crease the num­ber of treat­ment op­tions avail­able to pa­tients.

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Roger Perlmutter, Merck R&D chief (YouTube)

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