The FDA has approved a new product called Kisqali Femara Co-pack. It combines two medicines: ribociclib (Kisqali) and letrozole (Femara) in one package. This co-pack is for adults with a certain type of breast cancer called HR-positive, HER2-negative. It is approved for two uses. First, it can be used after surgery for patients with stage II or III early breast cancer who have a high risk of the cancer coming back. Second, it can be used as the first hormone-based treatment for patients with advanced or metastatic breast cancer that has spread. The co-pack makes it easier for patients to take both medicines together. However, the dose of ribociclib is different for each use: 400 mg for early breast cancer and 600 mg for advanced breast cancer. Both are taken for 21 days followed by 7 days off. Letrozole is taken daily at 2.5 mg. This approval does not change the standard of care but provides a convenient option. If you have questions about whether this treatment is right for you, talk to your doctor.
FDA approved Kisqali Femara Co-pack (ribociclib/letrozole) for HR+/HER2- Early and Advanced Breast CancerFDA approved Kisqali Femara Co-pack for two types of breast cancer.
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The FDA has approved Kisqali Femara Co-pack, a co-packaged product containing the kinase inhibitor ribociclib and the aromatase inhibitor letrozole, for two indications in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. First, it is indicated for adjuvant treatment of adults with stage II and III early breast cancer at high risk of recurrence. Second, it is indicated as initial endocrine-based therapy for adults with HR-positive, HER2-negative advanced or metastatic breast cancer. This approval provides a convenient co-packaged option for patients requiring both ribociclib and letrozole. Clinicians should note that dosing differs between the early breast cancer indication (ribociclib 400 mg) and the advanced/metastatic indication (ribociclib 600 mg), both on a 21-days-on, 7-days-off schedule, with letrozole 2.5 mg daily continuously.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Ribociclib is a kinase inhibitor that inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are involved in cell cycle progression. Letrozole is an aromatase inhibitor that inhibits the conversion of androgens to estrogens, reducing estrogen levels in both early and advanced breast cancer.
Kisqali Femara Co-pack is indicated for: (1) adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence; (2) as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer. Pre/perimenopausal women or men treated with this co-pack should also receive a luteinizing hormone-releasing hormone (LHRH) agonist.
For early breast cancer: ribociclib 400 mg (two 200 mg tablets) orally once daily for 21 consecutive days followed by 7 days off, in 28-day cycles; letrozole 2.5 mg (one tablet) once daily continuously throughout the 28-day cycle. Treatment should continue for 3 years or until disease recurrence or unacceptable toxicity. For advanced or metastatic breast cancer: ribociclib 600 mg (three 200 mg tablets) orally once daily for 21 consecutive days followed by 7 days off, in 28-day cycles; letrozole 2.5 mg once daily continuously. Dose modifications for adverse reactions are specified in the label, including reductions for neutropenia, hepatobiliary toxicity, or QT prolongation. If a dose reduction below 200 mg/day is required, discontinue ribociclib.
Trial data not available in label.
Warnings include interstitial lung disease/pneumonitis and cutaneous adverse reactions including severe cutaneous adverse reactions (SCARs). Dose modifications and management are recommended based on grade. No contraindications are listed in the provided label text.
Kisqali Femara Co-pack provides a co-packaged option for CDK4/6 inhibitor plus aromatase inhibitor therapy in HR+/HER2- breast cancer, covering both early (adjuvant) and advanced/metastatic settings. The co-pack simplifies administration by combining both medications in a single package.
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