Thursday, December 16, 2010

US FDA recommending to remove breast cancer indication label drug Avastin bevacizumab

US FDA recommending to remove breast cancer indication from the label for drug Avastin (bevacizumab)

The United States Food and Drug Administration has made and announcement that they are recommending to remove breast cancer indication from the label for drug Avastin (bevacizumab) as it lacked the safety and effectiveness for use in treatment of breast cancer.

US FDA said that removing the breast cancer indication from the Avastin (bevacizumab) label will be a process and the drug is not removed from market, this action will not affect the approvals for Avastin (bevacizumab) for its use in treating colon, kidney, brain, and lung cancers. Hence it can be used for treating colon, kidney, brain, and lung cancers.

US FDA has asked all oncologists currently treating patients with Avastin for metastatic breast cancer that they should use their own medical judgment for deciding whether a patient should continue treatment for breast cancer with the drug Avastin (bevacizumab) or to consider other therapeutic options.

The US FDA in its press release mentioned that they have decided to make this recommendation after thorough reviewing of the results of four clinical studies of Avastin in women suffering from breast cancer , US FDA said they are determining that the data from these clinical studies indicate that the treatment with drug Avastin (bevacizumab) in women suffering from breast cancer is not able to prolong overall survival neither it is able to provide a sufficient benefit in slowing breast cancer progression which can outweigh the risks posed by drug Avastin (bevacizumab) to patients.

Serious risks associated with the use of drug Avastin (bevacizumab) are bleeding and hemorrhage; severe high blood pressure; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.Avastin is also associated with other serious and potentially life threatening side effects like risk of stroke, wound healing complications, organ damage or failure; and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures, and vision loss from swelling of the brain.

An independent advisory committee members comprising of oncologists primarily, had voted 12-1 for removal of the indication of breast cancer indication from Avastin’s label.
It was observed in post market safety studies that none of the studies were able to demonstrate that patients receiving Avastin lived longer where as the patients receiving Avastin experienced a significant increase in serious side effects. The limited beneficial effects of Avastin are very limited and are associated with the significant risks.

In Feb 2008 US FDA had approved drug Avastin , in combination with chemotherapy (paclitaxel), for treating breast cancer under the US FDA’s accelerated approval program, through which a drug is approved while confirmatory clinical trials are conducted based up on data which suggest the drug has a good clinical benefit for providing treatment in diseases which are considered to be affecting patients life seriously, and to provide life saving treatment options in such conditions , by providing earlier patient access to promising new drugs. Similarly Avastin was approved based on its clinical trial(“E2100,”) results , which evaluated the drug in patients who had not received chemotherapy for their metastatic HER2-negative breast cancer.

With a hope for providing a treatment option in breast cancer patients with better the FDA stated in its press release that 'they are encouraging the US base Biotechnology , Pharmaceutical company Genentech to conduct additional research to identify if there may be select groups of patients who might benefit from this drug ,where as the Genentech has not agreed to remove the breast cancer indication voluntarily", hence the US FDA has issued a Notice of Opportunity for a hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination. US FDA stated further in its press release that Genentech has 15 days to request a hearing; if it does not do so, the hearing will be waived, and the US FDA will begin proceedings to remove the breast cancer indication.

US FDA stated further in its press release that they are open to working with US base Biotechnology , Pharmaceutical company Genentech on any proposals to conduct additional studies of Avastin in patients with metastatic breast cancer designed to identify a population of patients in which the drug’s benefits exceed the risks.

Information about bevacizumab.

Bevacizumab are monoclonal antibodies which are humanized* these antibodies are capable of recognizing and blocking vascular endothelial growth factor A (VEGF-A), it is a protein which is encoded by the VEGFA gene in human , it is considered as a chemical which signals and stimulates angiogenesis ( the formation or growth of new blood vessels) which is a very important factor for proliferation of cancerous cells , retinal proliferation of diabetes in the eye, and other diseases.

Bevacizumab also inhibits the growth of normal blood vessels, and in turn the body's normal healing and maintenance.

Bevacizumab is found to be very effective in treating diseases of the eye ,where it is administered as injection in to vitreous cavity of the eye ball, serving a localized effect in eyes, in conditions like age related macular degradation (AMD), diabetic retinopathy where blood vessels around retina grow abnormally and causes separation of retina as retinal fluid leaks, causing serious damage to vision.

*Humanized antibodies: are antibodies derived from non human species by altering protein sequence so as to closely match the antibodies produced in humans.

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