FDA

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.

Already armed with the FDA’s breakthrough therapeutic designation, Novartis would appear to be on a short path to a near-term approval in early 2017, setting up a showdown with Pfizer’s pioneering Ibrance (palbociclib).

The priority review will also likely get the pharma giant’s drug out into a market well ahead of Eli Lilly, which is bullish about its chances with the rival CDK 4/6 drug abemaciclib. Last summer Lilly was forced to concede that it was not able to end its pivotal study early, leaving a final readout in 2017 and possibly no approval before 2018, giving Novartis a clear shot at making a splash in the market well ahead of abemaciclib’s arrival.

The headline figure from ESMO, based on a study that was wrapped early due to its success, was that ribociclib combined with letrozole reduced the risk of death or progression by 44% among first-line patients compared to letrozole alone.

That’s all in line with analysts’ estimates of peak sales breaking $2 billion.


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RAPS Regulatory Convergence 2017