Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations

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.

It is a sign of how rapidly and efficiently FDA is moving on cancer drug approvals that some investors were starting to get nervous about Roche/Genentech Inc.’s T-DM1 application as the user fee review deadline approached.

The drug—which combines a targeted cytotoxic agent with an antibody based on Genentech’s blockbuster Herceptin (trastuzumab) molecule—was proven to extend...

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