The FDA has informed Roche/Genentech that it will not grant accelerated approval of the BLA submitted in support of their T-DM1 therapy for breast cancers. The phase II trial did not meet the agency's criteria for approval because all treatment choices approved for metastatic breast cancer were not included in the study.
Roche/Genentech will still take the drug into Phase III and will resubmit a BLA in mid-2012. Due to the FDA's decision, Immunogen will now have to wait for its next milestone payment. If the BLA had been accepted, Immunogen would have earned a payment from Genentech.
Trials will go on and there is no reason to believe the drug is in trouble. It just won't get accelerated status. See Fierce Biotech story.
Posted by Bruce Lehr August 27th 2010.