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Alert Number 252

Campath as Frontline Therapy

Date: September 24, 2007

The U.S. Food and Drug Administration has just granted approval for single-agent Campath for the treatment CLL as frontline therapy. Campath was initially approved in 2001 but only for relapsed cases, or in combination with other drugs. This is an important hurdle for Campath. It is now the only monoclonal antibody that has been approved for use as single agent and in previously untreated CLL patients.

Notwithstanding the glowing press releases from the company's marketing machine, the million dollar question is this: now that we have access to this drug as frontline therapy, is Campath the slam dunk choice for untreated patients?  Do we now have a brand new “gold standard” for treating CLL patients? In our latest article Jumping the Gun we review the clinical trial that led to FDA approval, and it implications. This is a case where the PR hoopla may be overtaking clinical significance.

Just because you couldda, does it mean you shouldda, or wouldda?

Be well,


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