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.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA