Novartis’s Metastatic Breast Cancer Drug Kisqali Gets European Approval
Novartis AG has received European Union approval for its drug Kisqali (ribociclib) as first-line treatment for a tough-to-treat breast cancer, bolstering the Swiss drugmaker’s bid to challenge U.S. rival Pfizer’s Ibrance.
Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis.
Novartis can now compete with Ibrance (palbociclib) on two fronts as it tries to chase down Pfizer’s drug, which brought in $2.1bn in sales last year and – according to EvaluatePharma – will grow into a $6bn product in 2022, well ahead of Kisqali which it says will be a $1.6bn brand by that year.
The drug is to be used in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
“This approval of Kisqali reinforces our recognized leadership in cancer research and our commitment to innovative targeted therapies,” said Bruno Strigini, CEO, Novartis Oncology.
“We are proud of our collaboration with study investigators and patients, which provides the medical community with an important new treatment option for women with advanced or metastatic breast cancer.”
The drug was developed from a strategic research collaboration between Astex, and Novartis Institutes for BioMedical Research (NIBR) struck in 2005.
About 55,000 women are diagnosed with breast cancer a year in the United Kingdom alone. The drug’s safety and efficacy were confirmed in its pivotal phase 3 clinical trial, MONALEESA-2, which showed the drug, in combination with letrozole, reduced the risk of disease progression or death by 43 percent versus using letrozole alone
The trial also demonstrated the Kisqali plus letrozole combination had a median progression-free survival (PFS) of 25.3 months versus 16.0 months for letrozole alone. Kisquali also saw a 76 percent reduction in tumor size after eight weeks, compared with 67 percent for the single use of letrozole.
“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,” said Dr Mark Verrill, consultant medical oncologist at the Freeman Hospital, Newcastle.
“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.”
This decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Additional regulatory filings are underway with other health authorities worldwide.
