Experts: Revoke Avastin approval as breast cancer treatment

A panel of experts on Tuesday recommended that the US Food and Drug Administration (FDA) withdraw approval of Roche's best-selling cancer drug Avastin for the treatment of breast cancer.

Experts on the advisory panel voted 12 to one to recommend that the FDA remove the indication from Avastin's label that the drug be used with chemotherapy to treat advanced breast cancer.

The recommendation came after trials showed that taking Avastin did not benefit patients with metastatic breast cancer and "that there were, indeed, more side effects when patients took Avastin," FDA spokeswoman Karen Riley told AFP.

Avastin had been approved for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.

The final decision on whether to remove the breast cancer indication from the Avastin label will be taken by the FDA and will only affect the use of Avastin to treat breast cancer patients in the United States.

"The recommendation does not impact the use of Avastin for advanced breast cancer in other countries," Genentech, the Roche-owned pharmaceutical company that makes Avastin, said in a statement.

Riley was unable to say when the FDA will make its decision on whether or not to remove the breast cancer indication from Avastin's US label. Genentech said the decision was expected by mid-September.

The panel's recommendation does not affect the use of Avastin to treat other cancers, including colon and lung cancers.

kdz/sah

 

Life and Style
ebookNow available in paperback
ebooks
ebookA delicious collection of 50 meaty main courses
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Online Sales and Customer Services Executive

    £15000 - £18000 per annum: Recruitment Genius: An On-line Sales & Customer Ser...

    Recruitment Genius: Accounts Assistant - Fixed Term Contract - 6 Months

    £15000 per annum: Recruitment Genius: One of the largest hospitality companies...

    Recruitment Genius: Electricians - Fixed Wire Testing

    £28000 - £32000 per annum: Recruitment Genius: As a result of significant cont...

    Recruitment Genius: Customer Service Advisor

    £16575 - £19000 per annum: Recruitment Genius: An excellent opportunity is ava...

    Day In a Page

    Seifeddine Rezgui: What motivated a shy student to kill 38 holidaymakers in Tunisia?

    Making of a killer

    What motivated a shy student to kill 38 holidaymakers in Tunisia?
    Ajmer: The ancient Indian metropolis chosen to be a 'smart city' where residents would just be happy to have power and running water

    Residents just want water and power in a city chosen to be a ‘smart’ metropolis

    The Indian Government has launched an ambitious plan to transform 100 of its crumbling cities
    How to stop an asteroid hitting Earth: Would people co-operate to face down a global peril?

    How to stop an asteroid hitting Earth

    Would people cooperate to face a global peril?
    Just one day to find €1.6bn: Greece edges nearer euro exit

    One day to find €1.6bn

    Greece is edging inexorably towards an exit from the euro
    New 'Iron Man' augmented reality technology could help surgeons and firefighters, say scientists

    'Iron Man' augmented reality technology could become reality

    Holographic projections would provide extra information on objects in a person's visual field in real time
    Sugary drinks 'are killing 184,000 adults around the world every year'

    Sugary drinks are killing 184,000 adults around the world every year

    The drinks that should be eliminated from people's diets
    Pride of Place: Historians map out untold LGBT histories of locations throughout UK

    Historians map out untold LGBT histories

    Public are being asked to help improve the map
    Lionel, Patti, Burt and The Who rock Glasto

    Lionel, Patti, Burt and The Who rock Glasto

    This was the year of 24-carat Golden Oldies
    Paris Fashion Week

    Paris Fashion Week

    Thom Browne's scarecrows offer a rare beacon in commercial offerings
    A year of the caliphate:

    Isis, a year of the caliphate

    Who can defeat the so-called 'Islamic State' – and how?
    Marks and Spencer: Can a new team of designers put the spark back into the high-street brand?

    Marks and Spencer

    Can a new team of designers put the spark back into the high-street brand?
    'We haven't invaded France': Italy's Prime Minister 'reclaims' Europe's highest peak

    'We haven't invaded France'

    Italy's Prime Minister 'reclaims' Europe's highest peak
    Isis in Kobani: Why we ignore the worst of the massacres

    Why do we ignore the worst of the massacres?

    The West’s determination not to offend its Sunni allies helps Isis and puts us all at risk, says Patrick Cockburn
    7/7 bombings 10 years on: Four emergency workers who saved lives recall the shocking day that 52 people were killed

    Remembering 7/7 ten years on

    Four emergency workers recall their memories of that day – and reveal how it's affected them ever since
    Humans: Are the scientists developing robots in danger of replicating the hit Channel 4 drama?

    They’re here to help

    We want robots to do our drudge work, and to look enough like us for comfort. But are the scientists developing artificial intelligence in danger of replicating the TV drama Humans?