The clinical trial added IBRANCE (palbociclib) to letrozole hormonal therapy and compared the results to letrozole plus a placebo. The 666 participants have estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) breast cancer in an advanced or metastatic stage.
“PALOMA-2 represents the third randomized study to demonstrate the benefit of IBRANCE when added to hormonal therapy in the management of women with ER+, HER2- advanced breast cancer," Pfizer Chief Medical Officer and SVP Dr. Mace Rothenberg said. "IBRANCE remains the only CDK 4/6 inhibitor with Phase 3 data in this disease. These results provide confirmatory evidence for PALOMA-1 and will be used to support regulatory submissions around the world, including a request for conversion of IBRANCE from accelerated to full approval in the United States. We look forward to sharing the detailed results of PALOMA-2 with the oncology community and advancing our discussions with regulatory authorities.”
IBRANCE is a first-in-class cyclin-dependent kinase (CDK) inhibitor approved by the U.S. Food and Drug Administration (FDA) to treat postmenopausal women with breast cancer. CDKs 4 and 6 regulate cell growth; IBRANCE inhibits the progression of the cell cycle. More than 25,000 women have been treated with IBRANCE since its approval in February 2015.
The results of the PALOMA-2 trial will be presented at the 2016 meeting of the American Society of Clinical Oncology (ASCO).
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