FDA approves Genentech's Perjeta for early-stage breast cancer

Drug already approved for late-stage disease

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

The FDA announced the approval of Genentech's Perjeta (pertuzumab) for the new usage, known as neo-adjuvant breast cancer treatment. The drug was already approved last year for certain breast cancers that had spread to other parts of the body. The new usage is intended for patients with breast cancer that includes increased amounts of the HER2 protein — as 20% of breast cancer cases do — whose disease is locally advanced and who are at high risk of the cancer spreading elsewhere in the body.

"We are seeing a significant shift in the treatment paradigm for early-stage breast cancer," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences."


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