Data supports fast approval for Roche's breast cancer drug -FDA staff
Sept 10 (Reuters) - Trial data on Swiss drugmaker Roche's breast cancer treatment Perjata supported a faster approval of the drug for use in early stages of the disease, reviewers for the U.S. Food and Drug Administration said on Tuesday.
The FDA review team believed that the totality of the data submitted, including study results and the drug's safety profile, supported an accelerated approval, documents posted on the FDA's website on Tuesday said. ()
Roche is seeking approval for Perjata as a neoadjuvant, or initial, treatment for early stage breast cancer patients whose cancer cells contain increased amounts of the HER2 protein.
A neoadjuvant treatment is given in the beginning to shrink a tumor before the main treatment.
If approved, Perjeta, to be used in combination with Roche's older breast cancer drug Herceptin and chemotherapy drug docetaxel, would be the first neoadjuvant breast cancer treatment approved by the FDA.