A Consent Decree By Other Means?
This article was originally published in RPM Report
Here is the list of manufacturing commitments Roche/Genentech accepted to receive approval of Kadcyla (T-DM1, ado-trastuzumab emtansine). FDA's redactions are designated with brackets.
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FDA has raised questions about manufacturing and quality control during the review of two recently approved Roche/Genentech cancer drugs. At the same time, Roche is highlighting its leading presence and competency in biologics manufacturing as a core asset for the company.
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.