Thanks very much, PB, for the link to the abstracts. You can get a total of ten if you search for bexxar's (whadda ya call it, "scientific" name?) "tositumomab." Boy, that just rolls off the tongue, doesn't it?
Most of the abstracts slice and dice the trial and expanded access program data in interesting ways without any earthshaking revelations. There is an abstract on fludarabine and bexxar. "No patient developed anti-murine antibodies (HAMA). An investigator-assessed response was seen in 13 of 14 pts (93%) (2 CR, 11 PR) after fludarabine. Following treatment with Iodine I 131 tositumomab, 13 of 14 (93%) pts had a response (6 CR, 7 PR). Of the 11 PRs after fludarabine, 4 converted to CR." However, 5 pts (36%) had very low white blood counts (absolute neutrophil less than 500) and 1 patient had platelets less than 10K. So with fludarabine some of the trade offs of chemo return, not suprisingly.
Overall, in my admittedly biased view, the abstracts paint a picture of a very successful new treatment that should already be on the market, but for a regulatory agency that isn't satisfied with boxes upon boxes and disks upon disks of clinical data. |
