Novartis breast cancer drug Kisqali wins EU approval

Novartis has announced the launch of its new breast cancer drug Kisqali in the UK today following a green light from European regulators.

The selective cyclin-dependent kinase inhibitor can now be prescribed across Europe in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

The submission included data from the Phase III MONALEESA-2 trial, showing that Kisqali (ribociclib, formerly known as LEE011) plus letrozole cut the risk of progression or death by 43 percent over the latter drug alone, and demonstrated tumour burden reduction with a 53 percent overall response rate.

More than half of patients taking Kisqali plus letrozole remained alive and progression free at the time of interim analysis, therefore median progression free survival could not be determined. However, at a subsequent analysis with additional 11-month follow-up and progression events, a median PFS of 25.3 months for Kisqali plus letrozole and 16.0 months for letrozole alone was recorded, the drug giant said.

In the UK, around 55,000 women are diagnosed with breast cancer each year. Thirty percent of women with earlier stages of breast cancer will develop advanced disease, which is responsible for 90 percent of all breast cancer-related deaths. Eightyfive percent of women diagnosed with advanced breast cancer will not survive longer than five years, further highlighting the need for new treatment options.

Novartis says timely access to Kisqali now hangs on whether the National Institute for Health and Care Excellence agrees to fund its use on the NHS.

"The availability of treatments such as ribociclib is a significant clinical advance for women living in the UK with this type of breast cancer," said Dr Mark Verrill, consultant medical oncologist at the Freeman Hospital, Newcastle.

"Ribociclib, which is an oral treatment that can be taken at home, slows down the progression of advanced breast cancer for an average of over two years in combination with an aromatase inhibitor in postmenopausal women. I had first-hand experience of using ribociclib in the MONALEESA-2 trial, and look forward to a swift agreement with NICE so that access is not an issue for postmenopausal women in England and Wales who could be offered this new treatment."

News of Kisqali’s approval will also be welcomed by UK firm Astex Pharmaceuticals, which is eligible to receive a milestone payment as a result as well as subsequent royalty payments on sales as per the drug discovery alliance between the two firms, which stems back to 2005.