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Avastin Labeling Will Reflect New Data On Thromboembolic Events

This article was originally published in The Pink Sheet Daily

Executive Summary

Genentech's "Dear Doctor" letter cites evidence of an "increased risk of serious arterial thromboembolic events" related to use of the oncologic. A revised package insert containing more detailed information on arterial thromboembolic events across five studies is in development, the company says.

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Genentech's Avastin Gaining Market Share In On- And Off-Label Indications

Avastin's share in the first-line metastatic colorectal cancer setting reached 55% in the fourth quarter, up from 42% in the third quarter. Off-label use in the second-line increased to 41%. An August "Dear Doctor" letter on thromboembolic events may have had an impact on slower-than-expected fourth quarter sales of the oncologic.

Genentech's Avastin Gaining Market Share In On- And Off-Label Indications

Avastin's share in the first-line metastatic colorectal cancer setting reached 55% in the fourth quarter, up from 42% in the third quarter. Off-label use in the second-line increased to 41%. An August "Dear Doctor" letter on thromboembolic events may have had an impact on slower-than-expected fourth quarter sales of the oncologic.

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Updated labeling includes warning on arterial thromboembolic events described in August "Dear Healthcare Provider" letter. Patients treated with Avastin plus chemotherapy had a 4.4% incidence of thromboembolic events versus 1.9% in patients on chemotherapy alone.

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