Novartis breast cancer drug secures FDA fast-track status

pharmafile | November 1, 2016 | News story | Manufacturing and Production, Sales and Marketing Novartis, Pfizer, ibrance, letrozole, riboclib 

Novartis has announced that its product ribociclib (LEE011) has been granted fast-track review status as a first-line treatment of advanced breast cancer in postmenopausal women.

Thanks to its ability to meet this unmet medical need through efficacy data showing a progression-free survival rate 44% higher than letrozole alone in patients with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer, Novartis’ product’s review will be prioritised in an effort to reach patients as soon as possible.

This follows the drug’s acceptance for review by the European Medicines Agency (EMA) as a combination treatment with letrozole. The developments could prove to be a breakthrough for the Swiss firm and a bad news for Pfizer; if and when ribociclib hits the market, it will be looking to muscle in on the US company’s Ibrance drug and its $10,000 a month market lead.

Head of Novartis’s oncology business Bruno Strigini remarked: “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.”

Matt Fellows

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