FDA panel backs approval of Roche drug in early breast cancer
Sept 12 (Reuters) - Roche Holding AG's drug Perjeta, currently approved to treat metastatic breast cancer, should also be approved to help shrink tumors prior to surgery, an advisory panel to the U.S. Food and Drug Administration said on Thursday.
The panel voted 13 to 0, with one abstention, that the drug's benefits outweighed its risk in early breast cancer patients, even though the trial was small, with 107 patients taking Perjeta in combination with Roche's drug Herceptin and chemotherapy, and 107 taking Herceptin plus chemotherapy alone.
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