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FDA Panel To Review Genentech`s Avastin In Brain Cancer


Posted on: 03/09/2009

FDA Panel To Review Genentech's Avastin In Brain Cancer

 
Monday March 9th, 2009 / 16h44
 
 
DOW JONES NEWSWIRES Genentech Inc. (DNA) said a Food and Drug Administration committee will discuss on March 31 the biotechnology giant's application for Avastin for patients with previously treated brain cancer.
The application will be reviewed by the Oncologic Drugs Advisory Committee as part of the FDA's accelerated approval program that allows provisional approval of medicines for cancer and other life-threatening diseases based on preliminary evidence. A decision is expected by May 5.
The application is based on data from a Phase II Avastin trial involving 167 previously treated glioblastoma patients. A Phase III study will start later this year, to evaluate the safety and efficacy of Avastin in combination with radiotherapy and temozolomide for patients with newly diagnosed glioblastoma.
The cancer drug has been a major sales boost for Genentech and last year the drug's revenue rose 17% to $2.69 billion.
On Friday, Roche Holding AG (ROG.VX) increased its bid for the 44% of shares it doesn't already own to buy Genentech by 7.5% to $93. The new deal, worth $45.7 billion, is likely to succeed, according to analysts as Roche seeks to conclude an eight-month battle to gain full control of Genentech.
Shares were down 1.1% to $89.90 in recent trading.
-By John Kell, Dow Jones Newswires; 201-938-5285; john.kell@dowjones.com
Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: http://www.djnewsplus.com/access/al?rnd=uhZWDuT8N%2Fh45Ys7RP60FQ%3D%3D. You can use this link on the day this article is published and the following day.
 
Monday March 9th, 2009 / 16h44 Source : Dowjones Business News
 


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