Fludarabine

There is no great pressure to get oral fudarabine to the market (In the USA). Partly this is because of economic reasons - the way that reimbursement is scheduled provides perverse incentive to stick with the intravenous version. Partly it is that the FDA would seem to require all the clinical studies repeated with the oral version, and not just pharmacokinetic studies as was the case in Europe.
I am pretty sure that the oral form is not available in Germany either. (A licence has been applied for from the German authorities.)

12 April 2005

Is Fludarabine really necessary?

This is really a philosophical question. Patients with unmutated VH genes generally run into problems. Their bone marrow becomes infiltrated with CLL cells and they stop making normal red cells white cells and platelets. Their lymph nodes grow and cause symptoms. They develop autoimmune side effects.

Almost everyone I know believes that the way to combat this is to eliminate as many CLL cells as posible for as long as possible. If you accept this philosophy then fludarabine combinations are the best way of doing this. FCR or FCM or FR all have their advocates, but since there has been no head to head comparison, nobody knows which is the best way.

Before we had these treatments the average survival from diagnosis of the unmutated subset was 7-8 years. The hope is that the newer treatment will improve on this. No effective treatment is without side effects. We really need an objective assessment that the side efects of fludarabine containing regimens are trivial compared to the benefits. There are many subjective testimonies either way, but little objective quality of life evidence.