Zevalin

Some good news for Zevalin -- the FDA has agreed to drop one of the required steps, which should make it more attractive to oncologists.

Some background (since I haven't talked about Zevalin in a while): Zevalin, like Bexxar, is a type of RadioImmuno Therapy (RIT). It's essentially Rituxan (a monoclonal antibody that attaches to the protein CD20 on B cells, and then kills them off) with a little something extra: a tiny dose of radiation that gets delivered directly to the cancer cell (something that can't be done with traditional radiation treatments, since blood cells are moving targets). Zevalin has proven to be extremely effective for many patients, on its own and in combination with other treatments.

But Zevalin has some problems, too, mostly with the way it is administered: it's not given in an oncologist's office, like many treatments, but needs to involve a team of nuclear medicine folks.  There are also some problems with reimbursement that make it unattractive for some doctors.

The FDA's decision may help with some of this. There will no longer be a bioscan required as part of the procedure. Up until now, patients were given doses of Rituxan and Zevalin, with a bio distribution scan in between. The scan would help evaluate the effectiveness of the first doses to determine their effectiveness. The step, the FDA ruled, is not necessary. As a result, patients will be exposed to less radition, and there will be less coordination required between the oncologist and the nuclear medicine team.

The hope is that this will all make Zevalin a more attractive option. Its effectiveness has never been a question; the problem has always been the difficulty of making it happen.