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FDA Okays Novel Use Of Avastin For Treating Metastatic Colorectal Cancers

Genentech, a member of the Roche Group (RHHBY.PK), announced Wednesday that the U.S. Food and Drug Administration or FDA has approved the use of Avastin in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy, for the treatment of people ailing from metastatic colorectal cancer or mCRC.

Commenting on the approval, Hal Barron, chief medical officer and head of Global Product Development stated, "These people now have the option to continue with Avastin, plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

The company said that Avastin was the only biologic medicine approved by the FDA for the treatment of people with mCRC in combination with intravenous 5FU-based chemotherapy as an initial treatment, as treatment for people whose cancer worsened after chemotherapy alone, and now as a treatment for people whose cancer has worsened after initial treatment with an Avastin-based regimen.

Avastin which exhibited positive results from its Phase III ML18147 study, presented at the American Society of Clinical Oncology, reduced death risk by 19 percent with the median overall survival at 11.2 months compared with 9.8 months for patients who did not receive Avastin in combination with their chemotherapy procedures, said Genentech in a statement.

Also, Avastin reduced progression free survival or PFS-the risk of the cancer worsening or death progression-by 32 percent, with median PFS at 5.7 months compared to 4.1 months in the Avastin free treatment methodology.

by RTT Staff Writer

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