Roche, Genentech hit with refuse-to-file letter

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The FDA has handed Roche and Genentech a refuse-to-file letter for the developers' BLA for trastuzumab-DM1. The drug attaches ImmunoGen DM1 cancer-cell killing agent to Genentech's HER2-targeting antibody, trastuzumab. Roche submitted the BLA in July following a successful Phase II study in which the drug shrank tumors by one-third in women with late-stage breast cancer. The company had hoped to gain accelerated approval of the drug.

The FDA says the T-DM1 trials did not meet the agency's standards for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population, according to a statement. Genentech says it will continue an ongoing Phase III trial of the drug and hopes to submit a BLA in mid-2012.

"It goes without saying that we're disappointed by this decision of the FDA," said Immunogen CEO Daniel Junius in a conference call this morning. But he added that the BLA rejection "appears to be a technical issue, not a fundamental one." Immunogen was slated to receive a milestone payment upon the FDA acceptance of the Genentech BLA. Junius noted that, despite the fact that his company won't realize that payment in 2010 as planned, Immunogen has no plans at this time to cut its burn rate.

- check out the release
- read the Reuters article for more

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