Pfizer announced on Wednesday that Ibrance, the drug for breast cancer treatment had shown effective results in the first formal last-stage trial. The trial was stopped beforehand as the drug met the primary endpoint in delaying the disease progression in patients who were previously treated for breast cancer.
The combination of Ibrance plus fulvestrant in the phase 3 PALOMA-3 trial met its primary end point by demonstrating promising results in progression-free survival in women with advanced breast cancer, Value Walk reported. The trial was halted based on an assessment by an independent data- monitoring committee, reported the company, according to Nasdaq.
"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," said Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.
It is to be noted that Ibrance which was previously scheduled for approval on April 13, 2015 was approved for trial by FDA on Feb 3, 2015 under accelerated approval program. The drug was given accelerated approval based on the clinical data demonstrating its benefits in treating advanced stage breast cancer patients, according to the FDA press release.
Ibrance is for use in postmenopausal patients who had not received endocrine-based therapy for estrogen receptor (ER)-positive metastatic breast cancers and not in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancers. Ibrance inhibit the cyclin-dependent kinases (CDKs) 4 and 6, that promote cancerous cell growth in ER-positive metastatic breast cancer.