No­var­tis’ star can­cer drug lands on an in­side FDA track, rac­ing Lil­ly to a show­down with Pfiz­er

No­var­tis just got a help­ing hand from the FDA as it races against Eli Lil­ly to jump in­to a three-way tug of war with Pfiz­er over a block­buster can­cer drug mar­ket. The agency has giv­en its CDK 4/6 can­cer drug LEE011 (ri­bo­ci­clib) its break­through sta­tus, like­ly cut­ting months off the reg­u­la­to­ry re­view process.

No­var­tis gained a BTD — its 11th — for the drug in com­bi­na­tion with letro­zole for the treat­ment of hor­mone re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive (HR+/HER2-) ad­vanced or metasta­t­ic breast can­cer.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER