FDA Approves Taxol as Adjuvant Therapy for Node+ Breast Cancer

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 8 No 12
Volume 8
Issue 12

ROCKVILLE, Md-The Food and Drug Administration has approved a new indication for Bristol-Myers Squibb’s Taxol (paclitaxel) for use in the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-based combination therapy. The approval does not exclude patients with receptor-positive tumors, even though a subgroup analysis of the supporting data suggested no benefit in this group.

ROCKVILLE, Md—The Food and Drug Administration has approved a new indication for Bristol-Myers Squibb’s Taxol (paclitaxel) for use in the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-based combination therapy. The approval does not exclude patients with receptor-positive tumors, even though a subgroup analysis of the supporting data suggested no benefit in this group.

The approval came only a month after a unanimous recommendation for approval by the FDA’s Oncologic Drugs Advisory Committee (ODAC). (See Oncology News International, October 1999, page 4, for a full report of the meeting.)

At the ODAC meeting, Bristol-Myers Squibb presented data on more than 3,000 patients in a randomized phase III study. The results showed that the adjuvant use of Taxol reduced the risk of breast cancer recurrence in node-positive patients by 22% and reduced mortality by 28%, compared with patients who received doxorubicin-based chemotherapy alone.

The indication states: “In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone negative tumors.”

The agent was first approved in the United States in late 1992 for the second-line treatment of ovarian cancer. It has since won approval for use in breast cancer after failure of combination chemotherapy for metastatic disease; for the first-line treatment of ovarian cancer in combination with cisplatin (Platinol); for the second-line treatment of AIDS-related Kaposi’s sarcoma; and in combination with cisplatin for the first-line treatment of non-small-cell lung cancer.

Related Videos
Exercise and healthy lifestyles can lower the risk of cancer or the symptoms of cancer treatment despite having genetic dispositions, said Neil M. Iyengar, MD.
The Hispanic Breast Cancer Clinic at Northwestern Memorial Hospital includes a social worker, nurse practitioners, a medical oncologist, a radiation oncologist, and surgeons, says Claudia Tellez, MD.
The goal of creating the Hispanic Breast Cancer Clinic at Northwestern Memorial Hospital is to establish a safe space for Hispanic patients, says Claudia Tellez, MD.
Several factors may contribute to the low Hispanic breast cancer population at Northwestern Memorial Hospital, including a lack of resources and a focus on other disease types.
Sara M. Tolaney, MD, MPH, an expert on breast cancer
Sara M. Tolaney, MD, MPH, an expert on breast cancer
Sara M. Tolaney, MD, MPH, an expert on breast cancer
Hypofractionated radiotherapy yields less financial toxicity than conventionally fractionated radiotherapy in patients with breast cancer who have undergone reconstruction following mastectomy.
Related Content