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.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.