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
Related Content
Novartis shares new data about Fabhalta for IgAN treatment
Novartis has announced new results from a pre-specified interim analysis of its phase 3 APPLAUSE-IgAN …
Novartis shares new data for Zolgensma in children with SMA
Novartis has announced new data to continue the support of the clinical benefits of Zolgensma …
Pfizer’s Velsipity approved by EC for ulcerative colitis treatment
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) …