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34814911000001100

New Medicines

Kisqali Advanced HR-positive HER2-negative breast cancer in men - first-line

Information

Kisqali
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

CDK4/6 inhibitor, taken once daily for 21 days of a 28-day cycle.
Breast cancer is rare in men. There are about 350 men diagnosed each year in the UK. This compares to around 55,000 cases in women. About 1 in 100 (about 1%) of breast cancer cases in the UK are in males [1].
Advanced HR-positive HER2-negative breast cancer in men - first-line
Oral

KisqaliHR-positive, HER2-negative early breast cancer - adjuvant therapy

Information

Kisqali
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

CDK4/6 inhibitor, taken once daily for 21 days of a 28-day cycle.
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2 per 100,000 and the mortality 23.1 per 100,000. The incidence increased after the introduction of mammography screening and continues to grow with the ageing of the population. There is a steep age gradient, with about a quarter of breast cancers occurring before age 50, and <5% before age 35. Approximately 4-6% of breast cancers are metastatic at diagnosis [1].
HR-positive, HER2-negative early breast cancer - adjuvant therapy
Oral