Biocentury reports ...
Genentech, CDER submit joint statement on Avastin
Genentech Inc. and FDA's Center for Drug Evaluation and Research said in a joint statement they have been unable to agree on "the central questions that must be answered" for Commissioner Margaret Hamburg to render a decision about whether to withdraw metastatic breast cancer from the label of Avastin bevacizumab.
Instead of submitting a single joint list of facts in dispute, the parties submitted a partial list that includes whether actions by other regulatory authorities and data from studies outside the first-line setting are relevant. Each party now intends to submit a separate document summarizing what it considers to be the central questions to be presented and resolved. Genentech and CDER have until May 5 to submit their summaries.
Karen Midthun, who is the presiding officer for a hearing on the matter scheduled for June 28-29, had asked the Roche (SIX:ROG; OTCQX:RHHBY) unit and CDER to submit a joint statement outlining facts that are not in dispute and issues that are disputed.
