Roche's T-DM1 Early Filing Strategy Backfires As FDA Refuses To File BLA
This article was originally published in Pharmaceutical Approvals Monthly
FDA issued a refusal to file letter for Roche's BLA for trastuzumab-DM1 (T-DM1) for accelerated approval because all the available treatment choices approved for metastatic breast cancer had not been exhausted in the study population, Roche said Aug. 27
You may also be interested in...
Genmab and GlaxoSmithKline provided FDA with data from two trials to support the efficacy of Arzerra in refractory chronic lymphocytic leukemia, but the agency only considered a subset of one of the studies to count for proof of efficacy
The Oncology Drugs Advisory Committee's vote against full approval of Roche's Avastin (bevacizumab) for first-line treatment of metastatic breast cancer hinged to a large degree on its feeling that the drug did not delay disease progression long enough to be clinically meaningful
Although Pfizer's voluntary withdrawal of its acute myeloid leukemia therapy Mylotarg is the first complete withdrawal of an accelerated approval NDA, but as in other cases where the confirmatory trial fails to substantiate the initial signs of efficacy that supported the accelerated approval, FDA is not completely closing the door on access to the drug