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Friday, Sep 13
FDA panel backs use of Roche drug for early stage breast cancer
- An FDA advisory panel has recommended that the agency approve Roche's (RHHBY.OB) Perjeta drug for the pre-surgical, or neoadjuvant, treatment of breast cancer.
- If authorized for this indication, Perjeta could be used as an initial step to shrink tumors and so make surgery less invasive. Roche has estimated that 15,000 women a year could benefit.
- The FDA could make a decision next month.
- Perjeta has already been authorized for treating patients with HER2-positive advanced breast cancer that has spread.