The FDA has approved a new drug called Ibrance (palbociclib) for adults with a certain type of advanced breast cancer. This type is called HR-positive, HER2-negative. Ibrance is a kinase inhibitor, which means it works by blocking certain proteins that help cancer cells grow. It is used together with other hormone therapies, such as an aromatase inhibitor or fulvestrant. For some patients whose cancer has a specific change in the PIK3CA gene and is resistant to hormone therapy, Ibrance can be used with inavolisib and fulvestrant. This approval gives doctors and patients more choices for treating advanced breast cancer. It is important to note that Ibrance is not for everyone. It is only for patients whose cancer has the right hormone receptors and, in some cases, the PIK3CA mutation. If you or a loved one has advanced breast cancer, talk to your doctor about whether Ibrance might be a good option. Your doctor can help you understand the benefits and risks based on your specific situation.
FDA approved Ibrance (palbociclib) for HR-Positive, HER2-Negative Advanced Breast CancerFDA approved new drug Ibrance for certain advanced breast cancers.
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The FDA has approved Ibrance (palbociclib), a kinase inhibitor, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. The approval covers use in combination with an aromatase inhibitor as initial endocrine-based therapy, or with fulvestrant in patients who have progressed following endocrine therapy. Additionally, Ibrance is approved in combination with inavolisib and fulvestrant for patients with endocrine-resistant, PIK3CA-mutated disease, as detected by an FDA-approved test, following recurrence on or after adjuvant endocrine therapy. This approval provides a targeted option for patients with specific biomarker profiles and expands treatment choices in the advanced breast cancer setting.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy. IBRANCE is also indicated in combination with inavolisib and fulvestrant for adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
The recommended dose of IBRANCE is 125 mg taken orally once daily with food for 21 consecutive days followed by 7 days off treatment (28-day cycle). IBRANCE capsules should be swallowed whole and not chewed, crushed, or opened. If a dose is missed or vomited, an additional dose should not be taken; the next prescribed dose should be taken at the usual time. Dose interruptions and reductions are recommended for adverse reactions. The recommended dose modifications include first reduction to 100 mg/day and second reduction to 75 mg/day; discontinue if further reduction is required. For hematologic toxicities, monitoring of complete blood counts is required prior to therapy, at the beginning of each cycle, on Day 15 of the first 2 cycles, and as clinically indicated. Dose modifications for neutropenia and other hematologic toxicities are specified based on CTCAE grade. For non-hematologic toxicities, no dose adjustment is required for Grade 1 or 2; for Grade 3 or higher persisting despite optimal medical treatment, withhold until symptoms resolve to Grade 1 or lower. Pre/perimenopausal women should also be treated with an LHRH agonist; for men, consider LHRH agonist therapy.
Trial data not available in label.
Not reported in label.
IBRANCE is a kinase inhibitor indicated for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with endocrine therapy. It is used as initial endocrine-based therapy with an aromatase inhibitor or after progression on endocrine therapy with fulvestrant. Additionally, it is indicated for PIK3CA-mutated, endocrine-resistant disease in combination with inavolisib and fulvestrant.
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