Although breast cancer survival rates are higher than that of the other forms of cancer, chances of it reoccurring at the original site and spreading to other parts of the body is not entirely zero.
Breast cancer is the most frequently diagnosed cancer in women, and HER2-positive breast cancer accounts for 20 to 25 percent of all cases. The current standard of care in patients with early-stage breast cancer is chemotherapy and one year of Herceptin treatment following surgery.
About 20 percent of patients with HER2-positive early breast cancer see their cancer recur within five years following standard treatment.
Los Angeles-based Puma Biotech’s drug candidate intends to lower of the risk of the disease returning after initial treatment.
The drug, Neratinib — the first treatment of its kind — is designed to treat early-stage breast cancer in patients with the HER2 genetic mutation whose tumor has been surgically removed and who have been treated with Roche’s Herceptin.
The FDA earlier this week has announced the approval of Puma Biotechnology Inc’s experimental breast cancer drug candidate.
After two years, 94.2 percent of patients trea
ted with neratinib had not experienced cancer recurrence or death, compared with 91.9 percent of patients receiving a placebo, the FDA said in a statement.
