FDA: Avastin failed to live up to preliminary promise, Not for Breast Cancer

Today, FDA Panel say Avastin not for breast cancer, Avastin is not helpful in the treatment of metastatic breast cancer.

The recommendation does not affect the drug’s marketing for treatment of four other types of cancer. New trials failed to confirm initial studies indicating some benefit for breast cancer patients.

A U.S.Food and Drug Administration advisory panel called on the federal agency to withdraw its approval of Avastin as a breast-cancer treatment, media reported Wednesday. U.S. Food and Drug Administration panel recommended late Tuesday that a certain breast cancer use be removed from the company’s cancer drug Avastin.

Previously it had been thought that this combination might have serious adverse side effects, including life-threatening bleeding, for patients with non-squamous non-small-cell lung tumors. However, this phase 4 trial, which used Avastin  plus chemotherapy in a large population found these problems were minimal.

The FDA in 2008 gave Avastin “accelerated approval” for the treatment of spreading breast cancer, in combination with chemotherapy. As a condition of that approval, the manufacturer agreed to conduct two new clinical trials.

The FDA is not bound by the decisions of its advisory panels, which are made up of experts drawn from outside the FDA. However, it’s rare for the federal agency to buck a panel’s near-unanimous decision.

What is Avastin?

Avastin (pronounced ah-va’-stin) is an innovative tumor-starving therapy designed to block the VEGF (Vascular Endothelial Growth Factor) protein that is produced by normal cells and overproduced by cancer cells.

Avastin is not chemotherapy and therefore works differently. Avastin is a tumor-starving therapy because it starves the tumor of what it needs to grow and spread. Avastin works by blocking a protein called VEGF. This protein, VEGF, is produced by normal cells and overproduced by cancer cells. VEGF is important for the formation of blood vessels. Tumors rely on blood vessels to get the nutrients and oxygen they need to survive. By blocking VEGF, Avastin can starve your cancer of the food supply it needs to grow and spread. Blocking VEGF may be one way to fight your cancer.

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