The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based treatment for postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer [1]. The recommendation also covers its use in combination with fulvestrant for women who have received prior endocrine therapy [1].
What is Kisqali approved for in the EU?
Kisqali is recommended for marketing authorization in the European Union for two indications in advanced or metastatic breast cancer in postmenopausal women. The first is as initial endocrine-based therapy combined with an aromatase inhibitor [1]. The second indication is for treatment in combination with fulvestrant for patients who have progressed on prior endocrine therapy [1].
What is the mechanism of action for Kisqali?
Kisqali is a selective cyclin-dependent kinase (CDK)4 and CDK6 inhibitor [2]. By inhibiting CDK4 and CDK6, it disrupts the cell cycle progression, leading to the inhibition of tumor cell proliferation [2].
When might Kisqali's patents expire?
Drug patents are complex and can involve multiple patents covering different aspects of a drug, such as the compound itself, its formulation, or its method of use. Expiring patents can open the door for generic or biosimilar competition. Information on specific patent expiry dates for Kisqali is best accessed through specialized patent databases [3].
How effective is Kisqali in clinical trials?
The CHMP's recommendation was based on data from clinical trials. In the MONALEESA-7 trial, Kisqali in combination with goserelin and either tamoxifen or an aromatase inhibitor demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS) in premenopausal women with advanced breast cancer [4]. The MONALEESA-2 trial showed that Kisqali plus letrozole significantly improved PFS compared to letrozole alone in postmenopausal women with HR+, HER2- advanced breast cancer who had not received prior therapy for metastatic disease [5]. The MONALEESA-3 trial indicated that Kisqali plus fulvestrant improved PFS and OS in postmenopausal women with HR+, HER2- advanced breast cancer, regardless of menopausal status or prior treatment [6].
What are the risks associated with Kisqali?
The prescribing information for Kisqali highlights potential risks, including neutropenia, which is a low count of a type of white blood cell, and liver enzyme elevations [2]. Other potential side effects include diarrhea, fatigue, nausea, vomiting, headache, and hair loss [2]. Patients should discuss all potential risks and benefits with their healthcare provider.
How does Kisqali compare to other breast cancer treatments?
Kisqali is a CDK4/6 inhibitor, a class of drugs that has emerged as a significant advancement in the treatment of HR-positive, HER2-negative advanced breast cancer. Other CDK4/6 inhibitors available include palbociclib (Ibrance) and abemaciclib (Verzenio) [7]. These drugs are often used in combination with endocrine therapy to improve treatment outcomes. The choice of CDK4/6 inhibitor and endocrine therapy partner depends on factors such as patient characteristics, prior treatments, and clinical trial data [7].
What is the regulatory status of Kisqali in other regions?
Kisqali is approved in the United States by the Food and Drug Administration (FDA) for similar indications in advanced or metastatic breast cancer [2]. Regulatory reviews are ongoing in other regions, with decisions pending based on submitted data [1].
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Sources
[1] European Medicines Agency. (n.d.). CHMP recommends Kisqali for advanced breast cancer. Retrieved from https://www.ema.europa.eu/
[2] Novartis Pharmaceuticals Corporation. (2023). Kisqali Prescribing Information. Retrieved from https://www.pharma.us.novartis.com/our-pharmacy/kisqali
[3] DrugPatentWatch.com. (n.d.). Kisqali Patent Expiry. Retrieved from https://drugpatentwatch.com/
[4] ClinicalTrials.gov. (n.d.). Ribociclib and Goserelin With Tamoxifen or Aromatase Inhibitor in Treating Postmenopausal Women With Metastatic Breast Cancer (MONALEESA-7). Retrieved from https://clinicaltrials.gov/
[5] ClinicalTrials.gov. (n.d.). Ribociclib and Letrozole in Treating Postmenopausal Women With Advanced Breast Cancer (MONALEESA-2). Retrieved from https://clinicaltrials.gov/
[6] ClinicalTrials.gov. (n.d.). Ribociclib and Fulvestrant in Postmenopausal Women With Advanced Breast Cancer (MONALEESA-3). Retrieved from https://clinicaltrials.gov/
[7] National Cancer Institute. (n.d.). CDK4/6 Inhibitors. Retrieved from https://www.cancer.gov/