Susan G. Komen for the Cure® and Ovarian Cancer National Alliance Appeal to FDA and Key Lawmakers on Avastin Issue

Patient Access and the Impact on Development of New Treatments at the Heart of Komen for the Cure’s Concerns

DALLAS--(BUSINESS WIRE)--Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance (OCNA) today urged the U.S. Food and Drug Administration (FDA) to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic...

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WASHINGTON, DC -- August 10, 2010 -- Results from a late-stage study demonstrates that first-line use of bevacizumab in combination with paclitaxel and carboplatin provides a significant increase in overall survival for patients with nonsquamous with advanced non-small-cell lung cancer (NSCLC).

The data, published early online in the Journal of Thoracic Oncology, showed that bevacizumab in combination with chemotherapy led to a 3.9-month improvement in overall survival compared with...

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Source:biowire

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin’s U.S. label. The committee’s vote does not affect the current availability of Avastin for people with advanced...

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From Medscape Medical News
Neil Osterweil

July 20, 2010 – Toxicities associated with bevacizumab (Avastin) appear to be manageable when the drug is delivered as first-line therapy with various chemotherapy combinations to patients with nonsquamous nonsmall-cell lung cancer (NSCLC), report investigators from the international postmarketing study dubbed SAiL (Safety of Avastin in Lung).

In an uncontrolled open-label phase 4 study designed to reassure clinicians about...

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By MATTHEW PERRONE (AP) – 2 days ago

WASHINGTON — Federal health scientists said Friday that follow-up studies of a Roche breast cancer drug show it failed to slow tumor growth or extend patient lives, opening the door for a potential withdrawal in that indication.

The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on early-stage trials showing it shrank tumors caused by breast cancer. The decision was controversial because drugs for cancer...

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