The Federal Drug Administration (FDA) is on the verge of banning the use of Avastin in the treatment of breast cancer.
An FDA panel has found that the drug has been ineffective and unsafe in breast cancer treatment. The latest decision by an advisory committee to the FDA, which decided against the drug's continued use by 6-0 votes, will lead to the revoking of the drug's approval for use in breast cancer patients.
The FDA had earlier recommended the stoppage of the use of Avastin in breast cancer treatment after studies had found that the drug hardly made a difference in the longevity of patients undergoing treatment with it.
However, a significant section of breast cancer patients have said the FDA line is wrong. The Abigail Alliance, a platform of breast cancer patients and their relatives, has said the FDA is making a tragic mistake.
After the FDA panel announced the decision, it was immediately criticized by several patients. This was a kangaroo court ... There wasn't one dissenting thought up there, let alone one dissenting vote, said Steven Walker, co-founder of the Abigail Alliance, according to CBC News.
The Abigail Alliance is a platform that advocates for patient access to experimental medicine.
What do you want us to take!? We have nothing else! said a patient, Christi Turnage, of Madison, according to the report. She said her cancer has been undetectable for more than two years since starting therapy with Avastin.
“The FDA is making a tragic mistake by attempting to remove the approval of Avastin for breast cancer, without scientific merit,” according to the Alliance.
The FDA panel reiterated that the drug was neither safe nor effective and threw out manufacturer Genentech's plea that approval should not be revoked until fresh trials are done.
But the Abigail Alliance has refuted this claim.
The most recent trials of this drug actually confirmed that there is a progression-free survival advantage, just not as much of an advantage as the first trial indicated, which means the drug is having a positive effect - on average, and it is still impossible to statistically measure overall survival for a first-line breast cancer drug, the Alliance had said last year in a statement.
The most recent trials of this drug actually confirmed that there is a progression-free survival advantage, just not as much of an advantage as the first trial indicated, which means the drug is having a positive effect - on average, and it is still impossible to statistically measure overall survival for a first-line breast cancer drug, the Alliance said last year.
Avastin has been found hugely successful in the treatment of colon cancer. In 2008 the FDA approved its use in the treatment of breast cancer.
According to initial studies, the administration of Avastin prevented blood flow to tumors, thereby extending the amount of time before the tumor worsens. It was thought the drug could buy up to five months for the patient. However, later studies showed that the drug could not possibly be adding even one extra month of life.
The effectiveness of the drug was apparently too low to justify the high cost. It is calculated that a year's Avastin treatment would cost about $100,000. The drug was supposed to be administered to at least 17,500 breast cancer patients in one year.
Following studies that showed poor results, the FDA advisory panel voted 12-1 in July 2010 to cancel the endorsement of Avastin in breast cancer treatment. Following this, in December, FDA proposed to revoke approval of Avastin in breast cancer treatment, in combination with chemotherapy drug paclitaxel.
In 2008, Avastin had been given accelerated approval under a program that fast tracks the approval for drugs for serious diseases, meaning that the approval was subject to further trials.
Genentech, which makes the drug, said it was disappointed by the FDA panel's decision. We are very disappointed by the committee's recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options, it said. Genentech, a unit of Swiss drugmaker Roche Holding AG.
The decision to revoke Avastin's approval would mean a loss of millions of dollars for Roche. Avastin sales last year had brought in about $7 billion in revenue.
Though doctors would still be able to prescribe Avastin for other types of tumors, insurers will not pay for this expensive medicine. Avastin will remain on the market as a treatment for other cancers, including colon, lung and brain, so doctors could use it off label. But insurers might be less likely to pay for Avastin, which costs about $88,000 a year, according to Seattle Times.