Pfizer announced that Ibrance, its treatment for advanced cancer demonstrated impressive results during the late-stage trial, which was stopped early because of its efficacy.
According to the company, the Phase 3 PALOMA-3 trial from Ibrance met its primary endpoint. The treatment demonstrated improvement in progression-free survival (PFS) for the combination of Ibrance plus fulvestrant in women with advanced breast cancer.
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The patients in the trial have breast cancer classified as estrogen-receptor positive, human epidermal growth factor receptor 2-negative (ER+/HER2-).
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology said, “The results of this trial are especially important because they help us understand the potential of Ibrance to improve outcomes in patients with this difficult to treat cancer. We’re gratified to be able to stop the trial early.”
Pfizer is discussing a regulatory path forward for Ibrance
Ibrance delayed the progression of breast cancer significantly compared with Novartis AG’s Femara (letrozole), a member of another class of breast cancer treatments called aromatase inhibitors. Its efficacy accelerated the approval.
Pfizer is discussing with health authorities regarding a regulatory path forward for Ibrance.
Ibrance is a new anti-cancer medicine with a novel mechanism of the mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition. The U.S. Food and Drug Administration (FDA) approved Ibrance as first-line treatment for women with advanced breast cancer.
Successful trial results should boost demand for Ibrance
According to JPMorgan analyst, Chris Schott said the successful trial results should boost demand for Ibrance, which works differently than other approved cancer treatments. He said Pfizer has the potential to generate blockbuster sales.
Several analysts estimated that Pfizer could eventually generate annual sales of more than $5 billion from Ibrance.
Other pharmaceutical companies including Eli Lilly and Co are testing drugs that block cyclin-dependent kinase 4 and 6 that are involved in cell growth as potential cancer treatments. Ibrance are working to block these enzymes.