FDA通过审核批准抗癌药物Herceptin用于治疗接受手术后的HER2阳性的乳腺癌患者。Herceptin 是一种拮抗癌症细胞HER2蛋白的药物。过量HER2蛋白会促使癌症细胞快速生长，从而影响化学疗法的有效性。在1998年，FDA曾批准使用Herceptin来治疗转移性乳腺癌。这次FDA的审核批准扩大了Herceptin的治疗范围到局限性乳腺癌以及手术切除淋巴节的乳腺癌患者.Herceptin的使用仅限于HER2阳性的乳腺癌患者。

          A Expands Use of Herceptin for Early Stage Breast Cancer                                       After   Primary Therapy

The U. S. Food and Drug Administration (FDA) today expanded the approved use of Herceptin, a biological cancer drug. The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). Today's approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery. Herceptin should only be prescribed for women diagnosed with HER2 positive breast cancer. 

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