- Pfizer's advanced breast cancer drug, Ibrance (palbociclib), has been proven effective in women with advanced breast cancer who had previously been treated with anti-estrogen drugs.
- Ibrance received accelerated FDA in approval in February based on strong clinical trial data.
- Ibrance is approved for use in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer. It is the first FDA-approved cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and was approved as a breakthrough therapy because preliminary clinical evidence showed that it may offer substantial benefits over existing treatments.
In the Paloma 3 trial, which was stopped early based on positive results, women who were taking the anti-estrogen treatment, Faslodex (fulvestrant) combined with Ibrance were compared with women taking Faslodex alone. The women taking the combination therapy with Ibrance had better outcomes.
As Pfizer continues its extensive Ibrance clinical trial program, it is becoming clear that Ibrance is shifting treatment of breast cancer by becoming an important go-to agent for oncologists looking for effective treatment options for women with ER+/HER2- advanced breast cancer.
Next up is a trial in which Ibrance will be evaluated as part of combination treatment with Novartis's Femara (letrozole) for first-line treatment of women with advanced breast cancer.