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Biotech / Medical : Genentech (NYSE:DNA) formerly known as (NYSE:GNE)

DNA 11.29

-2.6%

12:13 PM EST

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To: DewDiligence_on_SI who wrote (67)	10/10/2005 9:04:10 PM
From: zeta1961	Read Replies (1) of 250

But they didn't tell us that new info has been added to the label indicating that Avastin/5fu/l was ineffective in 2nd and 3rd line patients(refractory to oxaliplatin and irinotecan) This is an electronic 'dear doctor' letter I received last week..I'da bought back my trading shares had I known-g- I own this in my LT but I have much trouble with their using marketing muscle in this highly competitive 'patient trial candidates' environment leaving some of the smaller co's floundering... _______________________________________________________________ Changes in the Avastin Package Insert Regarding Lack of Efficacy in Irinotecan- and Oxaliplatin-Refractory Metastatic Colorectal Cancer Avastin (Bevacizumab) was approved in February 2004 to be used in combination with intravenous 5-fluorouracil-based chemotherapy for the first-line treatment of patients with metastatic carcinoma of the colon and rectum. This email informs you of the following recent changes made to the Avastin prescription information: The inclusion of findings from NCI's Treatment Referral Center (TRC) study of Bevacizumab, infusional 5-fluorouracil, and leucovorin for the treatment of oxaliplatin- and irinotecan-refractory metastatic colorectal cancer into the Clinical Studies section of the package insert. This study, conducted in patients who had progressed following both oxaliplatin- and irinotecan-containing regimens, showed an absence of activity (as determined by objective tumor responses) in the third-line treatment of patients metastatic colorectal cancer. The following sentence is added as the final sentence to the first paragraph of the "Clinical Studies" section of the Avastin label: "The activity of AVASTIN in patients with refractory metastatic colorectal cancer was evaluated in a third, open-access trial in combination with intravenous 5-fluorouracil-based chemotherapy." A new subsection is added to the "Clinical Studies" section of the Avastin label as follows: "AVASTIN in Refractory Metastatic Colorectal Cancer Study 3 was a multi-center, single arm study that evaluated the activity of AVASTIN in combination with 5-FU/LV in 339 patients with metastatic colorectal cancer with disease progression following both irinotecan- and oxaliplatin-containing chemotherapy regimens. The majority (73%) of patients received concurrent 5FU/LV according to a bolus regimen. There was one objective partial response in the first 100 evaluable patients, for an overall response rate of 1% (95% CI 0-5.5%). The nature and severity of the adverse events observed in this trial were similar to that seen in the controlled clinical trials of AVASTIN." Full prescribing information, including clinical trial information, safety, dosing, drug-drug interaction, contraindications is available at www.fda.gov/cder/foi/label/2005/125085s45lbl.pdf. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by phone at 1-800-FDA-1088, by facsimile 1-800-FDA-0178 by mail using the Form 3500 at fda.gov

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