On Wednesday, British drug maker GlaxoSmithKline PLC announced today that the United States Food and Drug Administration (FDA) approved its breast cancer treatment Tykerb to be used with Roche Holding's Xeloda in patients with advanced breast cancer or breast cancer that has spread to other parts of the body.
The treatment is meant to be used in patients who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population.
Tykerb, a new molecular entity, is a kinase inhibitor working through multiple pathways (targets) to deprive tumor cells of signals needed to grow. Unlike, for example, trastuzumab - a monoclonal antibody, which is a large protein molecule that targets the part of the HER2 protein on the outside of the cell - Tykerb is a small molecule that enters the cell and blocks the function of this and other proteins. Because of this difference in mechanism of action, Tykerb works in some HER2 positive breast cancers that have been treated with trastuzumab and are no longer benefiting.
"Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2) positive breast cancer. The data clearly show that this small molecule, oral, targeted agent, in combination with capecitabine, is effective for women whose disease has progressed on previous therapies, including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice President of the Oncology Medicine Development Center at GSK. "The approval of TYKERB demonstrates our R&D organization's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of Tykerb in a variety of settings including adjuvant breast cancer as well as in other solid tumor types."
The approval of Tykerb was based on a randomized clinical trial in about 400 women with advanced or metastatic breast cancer that was also HER2 positive. In the trial, half the patients received Tykerb with capecitabine and half received capecitabine alone. Compared to patients receiving capecitabine alone, the group of patients receiving Tykerb with capecitabine had a statistically significant improvement in the time to tumor progression. In addition, the tumor response rate was higher in the group of patients receiving Tykerb with capecitabine (24 percent vs. 14 percent). The survival data are not yet mature.
Adverse events (AEs) leading to discontinuation were similar in the TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone (14 percent). Most commonly reported AEs in the TYKERB-capecitabine combination arm included diarrhea, hand-foot syndrome, nausea, rash, vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure of the strength of the heart's pumping capacity, was monitored during the study. Among 198 patients who received the TYKERB-capecitabine combination treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and one experienced a symptomatic (grade 3) decrease in LVEF.
The drug will cost $2,900 a month. Patients with a combined family income of less than $68,450 would be given the drug free of cost, the company said.
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