Kisqali (ribociclib) is a targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of advanced breast cancer. The approval was based on several clinical trials that demonstrated the drug's effectiveness and safety profile. Let's explore the key clinical trials that supported Kisqali's FDA approval.
MONALEESA-2: First-Line Treatment
The MONALEESA-2 trial investigated the efficacy and safety of Kisqali in combination with an aromatase inhibitor as a first-line treatment for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. The trial showed that Kisqali in combination with an aromatase inhibitor prolonged progression-free survival (PFS) compared to the placebo plus an aromatase inhibitor. Key findings include:
- The median PFS was 25.3 months with Kisqali plus an aromatase inhibitor, compared to 16.0 months with the placebo plus an aromatase inhibitor.
- Kisqali reduced the risk of disease progression or death by 44%.
These results demonstrated the benefit of using Kisqali as a first-line treatment option.
MONALEESA-3: Pre- and Perimenopausal Women
MONALEESA-3 evaluated the efficacy and safety of Kisqali in combination with a nonsteroidal aromatase inhibitor plus goserelin, a luteinizing hormone-releasing hormone agonist, in pre- and perimenopausal women with HR+/HER2- advanced breast cancer. Key findings from this trial are:
- Kisqali in combination with a nonsteroidal aromatase inhibitor plus goserelin significantly improved PFS compared to the placebo plus a nonsteroidal aromatase inhibitor plus goserelin.
- The median PFS was 20.5 months with Kisqali, compared to 12.8 months with the placebo.
This trial highlighted the benefit of Kisqali in younger patients with hormone-positive advanced breast cancer.
MONALEESA-7: Pre- and Perimenopausal Women with Advanced Breast Cancer
MONALEESA-7 explored the efficacy and safety of Kisqali in combination with endocrine therapy in pre- and perimenopausal women with HR+/HER2- advanced breast cancer. Key findings include:
- Kisqali in combination with endocrine therapy significantly improved PFS compared to endocrine therapy alone.
- The median PFS was not reached with Kisqali, while it was 13.0 months with endocrine therapy alone.
This trial further supported the use of Kisqali in pre- and perimenopausal women with advanced breast cancer.
Overall Safety Profile
In all the clinical trials mentioned above, Kisqali was generally well-tolerated. The most common adverse events reported were neutropenia (low levels of white blood cells), nausea, infections, fatigue, diarrhea, and leukopenia (low count of white blood cells). Close monitoring of blood counts is recommended during treatment with Kisqali.
Pricing Information
As of December 2021, the approximate monthly cost of Kisqali in the United States is $12,600. In the United Kingdom, the price is around £6,500, while in South Korea, it is approximately ₩8,600,000. In Japan, the cost is around ¥1,650,000, and in China, it is approximately ¥87,000. It's important to note that these prices are subject to change and may vary depending on various factors.
Relevant Locations
The clinical trials for Kisqali included various locations worldwide, including prominent medical centers in the United States (such as the National Institutes of Health and leading cancer centers), the United Kingdom, South Korea, Japan, and China. These locations were chosen to ensure a diverse study population and enable access to different patient populations.
Frequently Asked Questions
1. Is Kisqali a chemotherapy drug?
No, Kisqali is not a chemotherapy drug. It is a targeted therapy that works by inhibiting specific proteins involved in the growth and division of cancer cells.
2. Can Kisqali be used in all types of breast cancer?
No, Kisqali is indicated for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. It should be used in combination with an aromatase inhibitor or fulvestrant.
3. Can men with breast cancer use Kisqali?
No, Kisqali is currently only approved for the treatment of breast cancer in postmenopausal women or pre- and perimenopausal women who are receiving ovarian suppression.
References:
1. FDA Approval of Kisqali: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ribociclib-treatment-advanced-hr-positive-breast-cancer
2. Novartis Kisqali Prescribing Information: https://www.novartis.us/sites/www.novartis.us/files/ribo_cpi.pdf
