Watch out Pfiz­er, No­var­tis’ LEE011 bags quick OK for front­line use against breast can­cer

No­var­tis picked up a key reg­u­la­to­ry win to­day, gain­ing the FDA’s quick OK for LEE011, its CDK 4/6 drug now ap­proved as a front­line ther­a­py for post­menopausal women with hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive ad­vanced or metasta­t­ic breast can­cer in com­bi­na­tion with any aro­matase in­hibitor.

The drug, al­so known as ri­bo­ci­clib, hits the mar­ket as Kisqali with peak sales es­ti­mates of around $2.5 bil­lion a year, giv­ing the phar­ma gi­ant a clear shot at a new block­buster fran­chise.

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