Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

On April 1st I wrote about ODAC recommending approval for Genentech's Avastin in brain cancer, except it wasn't an April Fool spoof because the FDA approved it under the accelerated approval process for glioblastoma yesterday afternoon in patients who had progressed on other therapies. 

According to Genentech:

"The accelerated approval is based on independently reviewed data from
an open-label, multicenter, non-comparative Phase II study that
included 167 patients with glioblastoma that had progressed following
initial treatment with temozolomide and radiation. Patients were
randomized into two arms: Avastin alone or Avastin in combination with
irinotecan. A primary endpoint of the study was objective response
rate.  Response was assessed by magnetic resonance imaging (MRI) and
measured using World Health Organization radiographic criteria along
with decreased or stable corticosteroid use.  MRI does not necessarily
distinguish between the tumor, swelling (edema), or tissue death
(necrosis) caused by prior radiation therapy"

SOUTH SAN FRANCISCO, CA - JULY 14: A sign is ...Image by Getty Images via Daylife

It is the first real advance in a decade for patients with this disease since Temodar (temozolomide) was approved.  You can find more about the approval (including downloadable documents) at the FDA's website.  The approval was based on a review of several trials in this indication.

From the FDA documents, the following data emerged:

Study AVF3708g:
Tumor responses were observed in 26 percent of the 85 patients treated with Avastin alone, and the
median duration of response in these patients was 4.2 months (95%
confidence interval: 3.0 months, 5.7 months).

Study NCI 06-C-0064E
The efficacy of Avastin in glioblastoma that progressed following
prior therapy was supported by another study that used the same response
assessment criteria as AVF3708g.  This was a single-arm study of 56 patients
were treated with Avastin alone.  Responses were observed in 20 percent
of patients and the median
duration of response was 3.9 months.

The side effect profile appears to be in line with other approved indications for the therapy ie colorectal, lung and breast cancers.

No doubt more information will be available at the annual ASCO meeting later this month.

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