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Avastin U.S. sales dip

October 15, 2010 12:45 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) said in its 3Q10 earnings that U.S. sales of Avastin bevacizumab fell 3% on a local currency basis to CHF802 million ($817.7 million) compared to CHF851 million in the previous year's period. The company said the slower U.S. sales during the quarter were due to the regulatory and reimbursement uncertainty regarding the first-line HER2-negative metastatic breast cancer indication, for which the humanized mAb against VEGF has accelerated approval in combination with paclitaxel. In July, an FDA panel recommended removal of the indication from Avastin's label. In September, FDA extended its review of two sBLAs for Avastin in the indication seeking to include use in combination with additional chemotherapeutics by three months to Dec. 17 after a submission of additional data was deemed a major amendment. Avastin also is approved for metastatic colorectal cancer, non-squamous non-small cell lung cancer (NSCLC), metastatic renal cell carcinoma and glioblastoma.

Additionally, Roche said it discontinued development of Avastin for adjuvant colorectal cancer after it missed the primary endpoints in two previously reported Phase III trials in the indication. ...