Drug Information Update- Kisqali (ribociclib)
New Drug Approval:
On March 13th, 2017 the FDA approved Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Prescribing information is available here.
Drug Overview & Place in Therapy:
Kisqali (ribociclib) acts as an inhibitor of the cyclin dependent kinases (CDK) 4 and 6 and is the second CDK inhibitor approved for the treatment of breast cancer. Kisqali joins Ibrance (palbociclib), which has already been on the market for two years as first-line therapy in combination with letrozole for HR-positive, HER2-negative advanced breast cancer, and will compete with Ibrance in this population. Ibrance has an additional indication for use in combination with fulvestrant in women with disease progression following endocrine therapy for breast cancer. Studies of Kisqali in other breast cancer patient populations are currently being conducted but approvals expanding the indication are likely years away.
Ibrance has been a blockbuster product for Pfizer over the last two years with revenue reported at over $2 billion in 2016. While Ibrance already has an established place in this market, Kisqali is expected to compete in this large patient population.
Kisqali is administered orally for 21 consecutive days followed by 7 days off treatment. The efficacy of Kisqali was established in the phase 3 MONALEESA-2 trial which was stopped early at the first interim analysis, as Kisqali had met the primary endpoint and demonstrated a statistically significant improvement in progression-free survival (PFS) compared to letrozole alone.
The efficacy and safety profile of Kisqali are similar to Ibrance, except for a few notable differences in warnings and precautions. Kisqali has warnings regarding increased risk in QT prolongation and hepatobiliary toxicity and requires monitoring of EKGs and LFTs. In contrast, Ibrance has a warning regarding risk of pulmonary embolism but does not require additional specific monitoring. Both drugs have a risk of neutropenia and require monitoring of complete blood counts during the first few cycles of therapy.
Breast cancer is the most common invasive cancer among American women and the second leading cause of cancer death in women, second only to lung cancer. In 2016, the National Cancer Institute estimated that 246,660 new cases of breast cancer would be diagnosed and 40,450 women would die from breast cancer in the U.S. Over two-thirds of breast cancers are HR-positive and HER2-negative.
Utilization Management Strategies:
A full clinical review of Kisqali (ribociclib) will be conducted during the MedImpact 2nd Quarter 2017 Pharmacy & Therapeutics (P&T) Committee Meeting on Friday, April 21st. Upon receiving pricing information and reviewing effective cost management strategies, MedImpact will make final recommendations regarding formulary placement and utilization management.
NCCN Guidelines for Breast Cancer V1.2017 https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
Pfizer 4Q 2016 Earnings Press Release http://www.pfizer.com/system/files/presentation/Q4_2016_PFE_Earnings_Press_Release_dwerfks.pdf
Ibrance Prescribing Information http://labeling.pfizer.com/ShowLabeling.aspx?id=2191