FDA ODA Committee Recommends Accelerated Approval of Genentech's (DNA) Avastin for Brain Cancer

March 31, 2009 3:40 PM EDT

Genentech, Inc. (NYSE: DNA) announced today that the U.S. FDA Oncologic Drugs Advisory Committee voted unanimously that the response seen with Avastin(R) (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009.

An accelerated approval of Avastin for previously treated glioblastoma would provide doctors with safety and efficacy information and give people with this rapidly progressing brain cancer a new option. The application is based on positive, independently reviewed data from the non-comparative Phase II BRAIN study (AVF3708g) of 167 patients. In the 85 patients treated with Avastin alone, the trial showed:

• In 28%, tumors shrank to at least half their original size;
  
• In those whose tumors shrank, half experienced a response of at least 5.6 months;
  
• 43% lived six months without their disease getting worse; and,
  
• Half lived at least 9.3 months after starting treatment with Avastin and 38% survived longer than one year.

No new safety signals were observed in the trial and the safety profile was consistent with Avastin experience in other tumor types. The most common severe (Grade 3 or greater) adverse events in patients treated with Avastin alone were high blood pressure (8 percent) and seizures (6 percent). There were two deaths associated with adverse events in the group of patients treated with Avastin alone.

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