Novartis AG (NYSE:NVS) CDK4/6 breast cancer drug remains on track with Pfizer Inc’s (NYSE:PFE) Ibrance. The pharma giant has already obtained a regulatory pathway for its LEE011 from the FDA after going through the hurdle of priority review. The medication, which is in the line-up for the treatment of postmenopausal women who have advanced breast cancer, has also been acknowledged by the European Medicines Agency (EMA) for re-examination. This is a clear indication that the company is moving closer to a potential leapfrogging of Ibrance.
From its study results, presented at the ESMO 2016 Congress last month, Novartis explains that the combo of LEE011 as well as the standard hormone therapy Femara has close to 44% rate of reducing the risk of disease progression or death. This may not be the case with Femara alone.
Novartis looks set to be second to market
LEE011 was tested in women with tumors categorized as hormone receptor positive. If all goes well, the Swiss company will take second position in a market dominated by Pfizer.
Confident about the company’s performance, the head of Novartis’s oncology business, Bruno Strigini stated, “Priority Review allows a shorter review period compared with FDA standard review in the U.S., helping us to potentially bring LEE011 plus letrozole to patients more quickly”
It is not all about LEE011 for Novartis
The success of Novartis’ cancer drug is perhaps the beginning of brighter future for the company. At the very least, and for purposes of regulatory procedures, Novartis will be offering additional monitoring to patients using the med without necessarily having to put any physician burden on them.
However, Credit Suisse analysts feel that this safety responsibility may not obtain broader acceptance. The concerns might suprise Novartis, according to Credit Suisse’s Vamil Divan, who says that the company may even fall behind Eli Lilly, which is laying out its strategy with its rival abemaciclib. Meanwhile, Novartis’ closed its last trading session at $71.35, for an increase of $0.3 or 0.46%.