Kisqali

Kisqali can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer treatments.

Kisqali is available as tablets to take by mouth. The usual recommended dose is 600 mg once daily for 21 days followed by a 7-day break to complete a 28-day treatment course. Treatment courses are continued for as long as the medicine continues to work and the patient does not get unacceptable side effects. If the patient gets severe side effects the doctor may reduce the dose of Kisqali, or interrupt or stop treatment with the medicine.

For more information about using Kisqali, see the package leaflet or contact your doctor or pharmacist.

The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide. By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.

Kisqali was found effective in 3 main studies in women with HR-positive, HER2-negative advanced breast cancer.

In one main study involving 668 post-menopausal women with advanced breast cancer that had not been treated previously, patients received either Kisqali with letrozole (an aromatase inhibitor) or placebo (a dummy treatment) with letrozole. Women taking Kisqali with letrozole lived on average 25.3 months without the disease getting worse compared with 16.0 months in those taking placebo with letrozole.

Another main study involved 495 pre-menopausal women with advanced breast cancer that had not been treated previously and who received goserelin (an LHRH inhibitor) plus letrozole or anastrozole (aromatase inhibitors) combined with either Kisqali or placebo. Women taking Kisqali lived on average for 27.5 months without their disease getting worse compared with 13.8 months in those taking placebo.

A further study involved 726 post-menopausal women who had either not been treated previously or had received only hormonal treatment (to reduce the effects of oestrogen). Patients received fulvestrant either with Kisqali or with placebo. Patients taking Kisqali with fulvestrant lived on average for 20.6 months without their disease getting worse compared with 12.8 months for those receiving placebo with fulvestrant.

The most common side effects with Kisqali (which may affect more than 1 in 5 people) are infections, low levels of white blood cells, headache, cough, nausea (feeling sick), vomiting, diarrhoea, constipation, tiredness, hair loss and rash.

The most common severe side effects with Kisqali (which may affect more than 1 in 50 people) are infections, low levels of red and white blood cells, vomiting, abnormal blood tests for liver function and low levels of phosphate in the blood (hypophosphataemia).

Kisqali must not be used in patients who are hypersensitive (allergic) to any of the ingredients or to peanuts or soya.

For the full list of side effects and restrictions of Kisqali, see the package leaflet.

Kisqali used with an aromatase inhibitor or fulvestrant increased the time it took for the disease to get worse in women with HR-positive and HER2-negative breast cancer that was locally advanced or metastatic. Pre-menopausal and peri-menopausal women with advanced breast cancer also lived longer without their cancer getting worse when Kisqali was combined with an aromatase inhibitor plus a medicine to block LHRH. The European Medicines Agency considered that Kisqali’s pattern of side effects has been well established and the side effects are manageable.

The Agency therefore decided that Kisqali’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisqali have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Kisqali are continuously monitored. Side effects reported with Kisqali are carefully evaluated and any necessary action taken to protect patients.

Kisqali received a marketing authorisation valid throughout the EU on 22 August 2017.