Adverse Drug Reaction

Enrollment discontinued in Avastin platinum-refractory ovarian cancer study

Published in Medical Letter on the CDC and FDA, October 30th, 2005

Genentech, Inc., (DNA) announced that enrollment into a multicenter, single-arm, phase II study of Avastin (bevacizumab) in platinum-refractory ovarian cancer patients has been discontinued due to a higher rate of gastrointestinal (GI) perforations reported than in previous studies with Avastin.

Enrollment was discontinued following reports of 5 GI perforations observed in the first 44 patients enrolled in the proposed 53-patient study. The patients currently enrolled in the trial will be informed of the new safety information and, in consultation with their physician, may continue to receive protocol treatment with Avastin or elect to discontinue treatment.

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Source: Medical Letter on the CDC and FDA (2005-10-30)

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