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During a two-day meeting at the Food and Drug Administration offices outside of Washington, Genentech will provide evidence to support the company’s contention that the metastatic breast cancer approval of bevacizumab, in combination with paclitaxel, should not be withdrawn.
In December, the FDA proposed that the accelerated approval for this indication be pulled after two studies failed to show the magnitude of benefit on progression-free survival seen in an earlier study. Moreover, none of the trials showed an improvement in overall survival.
In an unprecedented move, Genentech appealed the decision, and the FDA granted the company the hearing.
During a two-day meeting at the Food and Drug Administration offices outside of Washington, Genentech will provide evidence to support the company’s contention that the metastatic breast cancer approval of bevacizumab, in combination with paclitaxel, should not be withdrawn.
In December, the FDA proposed that the accelerated approval for this indication be pulled after two studies failed to show the magnitude of benefit on progression-free survival seen in an earlier study. Moreover, none of the trials showed an improvement in overall survival.
In an unprecedented move, Genentech appealed the decision, and the FDA granted the company the hearing.
During a two-day meeting at the Food and Drug Administration offices outside of Washington, Genentech will provide evidence to support the company’s contention that the metastatic breast cancer approval of bevacizumab, in combination with paclitaxel, should not be withdrawn.
In December, the FDA proposed that the accelerated approval for this indication be pulled after two studies failed to show the magnitude of benefit on progression-free survival seen in an earlier study. Moreover, none of the trials showed an improvement in overall survival.
In an unprecedented move, Genentech appealed the decision, and the FDA granted the company the hearing.