Posted from: Thursday, May 04, 2017 - 04:30 PM - Present

Full Approval and Extended Indication for Ibrance

March 31, 2017 – The U.S. FDA converted the initial accelerated approval of Ibrance® (palbociclib) to regular approval. Ibrance, manufactured by Pfizer, now has full approval to be used along with any aromatase inhibitor (such as anastrozole, exemestane or letrozole), for the initial treatment of postmenopausal women who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Ibrance was the first cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor to receive FDA approval. The drug works by interfering with parts of cancer cell division. It has had accelerated approval for the first-line indication since February 2015, but only in combination with letrozole. Results from the Phase 3 PALOMA-2 trial showed that the average progression-free survival (PFS) time for women who took the combination of Ibrance with letrozole was a little over two years as compared to about 14.5 months for those taking a placebo with letrozole. It also has approval, combined with Faslodex® (fulvestrant - AstraZeneca) injection, as first-line therapy to treat HR+/HER2- breast cancer that has worsened after previous endocrine-based treatment. The recommended dosing is on 28-day cycles with one 125mg capsule taken daily on the first 21 days, only. The Ibrance dose may be reduced if side effects occur. 

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Last Updated Saturday, September 21, 2019 - 09:13 PM.