Regulatory Affairs

European Commission approves Novartis breast cancer drug Kisqali

Published 25 August 2017

Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.

Ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

“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."

In the UK, around 55,000 women are diagnosed with breast cancer each year3. Thirty per cent of women with earlier stages of breast cancer will develop advanced disease4, which is responsible for 90% of all breast cancer-related deaths1. Eighty five per cent of women diagnosed with advanced breast cancer will not live longer than five years5.

“We are delighted to receive European marketing authorisation for ribociclib in combination with an aromatase inhibitor. This is great news for so many postmenopausal women with the most common form of advanced breast cancer as the combination has proven to significantly increase the delay in disease progression over current standard of care,” said Barak Palatchi, General Manager of Novartis Oncology UK & Ireland. “The new NICE process to assess funding cancer medicines on the NHS is a welcome development and we are working closely with NICE to ensure eligible patients in England and Wales have access to ribociclib at the earliest opportunity.”

Ribociclib can be used in combination with letrozole, anastrozole or exemestane - giving oncologists the discretion to select the therapy they believe is most appropriate for each individual patient.

The EU licence follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was based on the superior efficacy and an acceptable safety profile of Kisqali plus letrozole versus placebo plus letrozole in the pivotal Phase III MONALEESA-2 trial.

The trial enrolled 668 postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer and showed that Kisqali plus letrozole, an aromatase inhibitor, reduced the risk of progression or death by 43% over placebo plus letrozole (median PFS=25.3 months (95% CI: 23.0-30.3) vs. 16.0 months (95% CI: 13.4-18.2); HR=0.568 (95% CI: 0.457-0.704; p<0.0001)2.

More than half of patients (55%) with measurable disease taking ribociclib plus letrozole experienced a tumour size reduction of at least 30 percent2. Adverse events are generally manageable with simple stepwise dose modification, allowing most patients to remain on treatment6.

Source: Company Press Release