Avastin should remain available to patients who need it most while Genentech undertakes another trial, the South San Francisco-based biotech company wrote in what amounts to the final argument in its appeal to maintain Food and Drug Administration approval in metastatic breast cancer.
In paperwork submitted Thursday to the FDA, Genentech said Avastin in combination with the chemotherapy drug paclitaxel should continue to be available while new labeling directs doctors to the “most appropriate” cases where breast cancer has spread to other parts of the body. It also said officials emphasize to doctors and patients the drug’s efficacy and safety data, “thus supporting informed decision-making regarding Avastin.”
Ultimately, FDA Commissioner Margaret Hamburg will decide yet this year whether to end approval of the world's best-selling cancer drug for women with metastatic breast cancer.
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