No­var­tis’s block­buster CDK 4/6 con­tender LEE011 gets a VIP count­down at the FDA

No­var­tis’s LEE011 (ri­bo­ci­clib) is get­ting VIP treat­ment at the FDA. A few weeks af­ter post­ing im­pres­sive late-stage da­ta for its CDK 4/6 drug, the agency has giv­en it a pri­or­i­ty re­view sched­ule, lop­ping four months off the usu­al reg­u­la­to­ry re­view.

No­var­tis adds that the EMA has al­so ac­cept­ed their ap­pli­ca­tion for first-line treat­ment of post­menopausal women with hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive ad­vanced or metasta­t­ic breast can­cer in com­bi­na­tion with letro­zole.

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