for oral use Initial U.S. Approval: 2015
palbociclib is a medication used for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.
Facts about palbociclib capsules
DISEASE INDICATIONS-Breast Cancer
MEDICINE APPROVED BY-European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
Palbociclib is indicated 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. It is indicated 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.
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Query For palbociclib capsules
Approved accessible "palbociclib capsules"
HR+ breast cancer
The drug was reviewed and approved under the Food and Drug Administration’s (FDA) accelerated Priority Review and Breakthrough Therapy designation programs on February 3, 2015 as a treatment (in combination with letrozole) for patients with estrogen receptor positive (ER+) advanced breast cancer. In March 2017, the FDA granted regular approval to palbociclib for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor.
The drug was approved for use in the European Union in November 2016 as a treatment for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer either in combination with an aromatase inhibitor or, for women who have received prior endocrine therapy, in combination with fulvestrant. In pre- or perimenopausal women, a luteinizing hormone releasing hormone agonist should also be given.
In December 2017, palbociclib, was accepted for use by the NHS after going through the Scottish Medicines Consortium's process for medicines used to treat very rare and end-of-life breast cancer.
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If palbociclib capsules are not yet approved or available in your area, you may request its price in India under a specific brand name through IPN. For assistance and guidance, you can contact us by providing complete details. Our pharmaceutical expert will help you find a suitable and practical solution to your query. To receive comprehensive support, please call us at +91 9891 296 838 (Mr. Tarun) / +91 9811 747 774 (Mr. Neeraj).
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