New Breast Cancer treatment

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The US Food and Drug Administration (FDA) Oncology Drug Advisory Committee is to meet tomorrow, Wednesday 5th December, to decide whether to recommend the agency approve Genentech Inc's cancer drug Avastin as a treatment for breast cancer. The FDA does not have to follow the advice of its advisory panels, which include practising physicians, but it usually does.

The panel will review two papers during the meeting. One paper is the drug company's application for approval supported by evidence from clinical trials. The other paper is a review of the clinical evidence by FDA staff.

Genentech want the FDA to extend its current approval to say that: "Avastin, in combination with paclitaxel, is indicated for the treatment of patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer."

The drug company's papers show evidence of significantly improved progression free survival rates (PFS) among clinical trial participants. In a study involving some 700 patients, the median PFS went up by 5.5 months. PFS measures how long before the cancer gets worse.

The FDA staff's review acknowledges the improved PFS rates from the Genentech clinical trials, but said this must be weighed against no significant change in overall survival, and more serious side effects, including death.

Avastin (bevacizumab) is currently approved by the FDA for treating patients with colon and non-small cell lung cancer with other drugs, although some doctors have started using it "off label" to treat breast cancer.

Avastin is not a chemotherapy drug, it's a monoclonal antibody that starves cancer tumours by blocking the growth of blood vessels to the tumours. The disadvantage of chemotherapy drugs is that they can also kill healthy cells.

http://www.medicalnewstoday.com/articles/90576.php

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breast, medication

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Mechka

1 Year, 2 Weeks, 1 day, 22 hours, 31 minutes ago

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