Experts: Revoke Avastin approval as breast cancer treatment
Wednesday 21 July 2010
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.
Harry Potter actor suffered 'severe flu-like symptoms' on a flight from London to Orlando
First full-length look is finally here
World cities ranked in terms of safety, food security and 'liveability'
Life & Style blogs
Snapchat removed the Best Friends list feature and 'stalkers' are upset
Baldness could soon be treated using stem cells, scientists hope
A bottle of wine a day is not bad for you and abstaining is worse than drinking, scientist claims
Eight-year-old girl Camilla Lisant suggests possible cancer treatment to her scientist father over the dinner table
Lack of medically trained staff leaves NHS 111 phone service struggling to cope, insider claims
- 1 Saudi preacher who 'raped and tortured' his five -year-old daughter to death is released after paying 'blood money'
- 2 The awkward moment Sarah Palin raised $25,000 for Hillary Clinton's election campaign
- 3 Ball pool for adults opens in London
- 4 Amal Clooney gives excellent response to fashion question at European Court of Human Rights
- 5 Baldness could soon be treated using stem cells, scientists hope
£19000 - £21000 per annum: Recruitment Genius: Are you a friendly, confident i...
Negotiable: Tradewind Recruitment: At Tradewind Recruitment we are currently l...
Negotiable: Tradewind Recruitment: Tradewind Recruitment is currently working ...
£28000 - £34000 per annum: Recruitment Genius: This is an exciting opportunity...