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