Custom Search

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.


=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to FDA guildelines for Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

What is Therapeutic Index ?

What is Narrow Therapeutic Range Drug?

What is High Efficiency Particulate Air( HEPA ) filter ?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?

CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines

What is High-Efficiency Particulate Air  HEPA Filter

What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.

What is a Site Master file of a pharmaceutical company

What is Generic Drug

What is Reference Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents

What are Post Market studies

Why a drug is bound to protein, What is protein binding?  What is drug absorption , distribution ?

Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic Resistance and Antibiotic resistance mechanism

Antioxidants food supplements

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Clean Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials

PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?

US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA

REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates


Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

Quality assurance in pharma industry

Quality by design concept for pharmaceutical industry

Quality by design concept in pharmaceutical industryan explanation

Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
What is Therapeutic Index ?

What is Narrow Therapeutic Range Drug?

What is What is a High-Efficiency Particulate Air (HEPA) filter ?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11.

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org