As I write this, Genentech (DNA Quote - Cramer on DNA - Stock Picks) is trading higher by nearly $1.40 per share to $71.25 after releasing positive data from the AVADO study, with Avastin measuring progression-free survival (PFS) in patients with metastatic breast cancer. I believe that the AVADO data is good, and again, it is the right stock reaction -- so far.
Passing the Test
The AVADO study was a placebo-controlled clinical trial that enrolled 736 patients with previously untreated, locally recurrent or metastatic HER2-negative breast cancer. Patients were randomized to one of two doses of Avastin or placebo in combination with another commonly used drug for breast cancer, docetaxel. The primary endpoint was PFS. Secondary endpoints included overall survival, response rate, time to treatment failure, quality of life and safety.
I believe this trial
may help to sway the Food & Drug Administration (FDA) to approve Avastin in this setting. The FDA is reviewing Genentech's supplemental Biologics License Application (sBLA) for the use of Avastin, in combination with paclitaxel chemotherapy, for the treatment of patients who have not received prior chemotherapy for their locally recurrent or metastatic HER2-negative breast cancer. As a reminder, the FDA is set to rule whether or not they'll allow an expanded label for Avastin in this indication on Feb. 23.
We don't know all the details of this study, as DNA wants to release them at a medical meeting or in a journal format, so all we know is that it demonstrated success in the progression-free-survival setting. The company did state in the press release that "The AVADO data are not included in the supplemental Biologics License Application currently under review by the FDA. However, we have shared the AVADO data with the FDA to assist the agency in assessing the risk and benefit of Avastin in this patient population."
Justin Ferayorni
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