FDA Reviewing Ibrance Combo as Standard Therapy for Metastatic Breast Cancer

FDA Reviewing Ibrance Combo as Standard Therapy for Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) is reviewing a request that Ibrance (palbociclib), in combination with Femara (letrozole), be used as a first-line therapy for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. The request, made in what the agency calls a supplemental New Drug Application (sNDA), was also granted priority review, meaning the FDA will aim for a decision within six months instead of the usual 10 months. The action date for the Prescription Drug User Fee Act (PDUFA) is set for April 2017. Ibrance, a first-in-class CDK 4/6 inhibitor that works to retard cell growth and division, and  Femara, an aromatase inhibitor that works to reduce the amount of estrogen produced in postmenopausal women, were granted accelerated approval as a combination regimen in February 2015. If the sNDA decision is favorable, the treatment will move to regular FDA approval. The sNDA is supported by data from the PALOMA-2 Phase 3 trial (NCT01740427), which included the same patient population as the Phase 2 PALOMA-1 trial (NCT00721409), whose findings were the basis for the FDA's accelerated approval of the therapy. “Since its introduction in 2015, more than 45,000 patients have been prescribed Ibrance by more than 9,000 providers in the U.S.,” Liz Barrett, global president and general manager, Pfizer Oncology, said in a
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