Is Ibrance (palbociclib) approved?
Palbociclib was approved by:
- Food and Drug Administration (FDA), USA:
- February 3, 2015, for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease
- On March 31, 2017, the accelerated approval was converted into a regular approval for use in combination with an aromatase inhibitor (an hormonal therapy) as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression following endocrine therapy
- On April 4, 2019, the approval was expanded to include the indication for men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer when Ibrance (palbociclib) is used in combination with an aromatase inhibitor or fulvestrant .
- European Medical Agency (EMA), European Union, November 11, 2016
and
- Therapeutic Goods Administration (TGA), Australia, May 3, 2017
- Health Canada, June 5, 2018
- Medsafe, 29 June, 2017
for use in combination with an aromatase inhibitor (e.g. letrozole) or with fulvestrant for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer who have received prior endocrine therapy.
How do I take Ibrance (palbociclib)?
The standard dosage is:
-
125 mg daily for 21 consecutive days, followed by 7 days of treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle.
Complete information about palbociclib dosage and administration can be found in the resources section.
Consult your treating doctor for personalised dosing.
Common adverse reactions or side effects of Ibrance (palbociclib)
Most common adverse reactions with palbociclib are:
- neutropenia
- leukopenia
- fatigue
- anemia
- infection
- nausea
Reviews
There are no reviews yet.