Guest guest Posted January 23, 2011 Report Share Posted January 23, 2011 Re: Re: FDA At 03:54 PM 1/10/2011, Rick Furman, MD wrote: >These are agents that are demonstrating remarkable effects in patients with refractory disease. One of the study sites for CAL-101 (in patients with relapsed or refractory CLL) is here in St. Louis (Washington Univ.). Initial results, after some of these patients have been taken off treatment with CAL-101, indicate that there is a rapid re-establishment of the disease pathologies. As a result, there is some thinking that these patients (particularly the refractory patients) will need to continue CAL-101, for the rest of their lives, or until any side-effects of CAL-101 become too much of a problem. From the context of few current treatment options for refractory patients, such an option of continued CAL-101 treatment, if efficacious in maintaining pathologies within a tolerable spectrum, would seem to be quite a successful outcome from the perspective of refractory patients. It would even seem that it is likely such reduction of potentially lethal pathologies would 'eventually' enable CAL-101 to demonstrate overall survival responses in refractory patients. However, if the FDA expects head-to-head comparisons with an approved CLL drug, I'm not sure I understand how that demonstration could be 'ethically' conducted in patients who are refractory to approved drugs. Question for Dr. Furman: Is this type of result (of rapid disease return) after withdrawing CAL-101 being generally observed in the studies of CAL-101 on refractory CLL patients? Al Janski Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 23, 2011 Report Share Posted January 23, 2011 We do not fully know. We have not stopped treatment on responding patients as of yet, and most of the refractory patients have had some flare, but then went on to other therapies. Rick Furman > >These are agents that are demonstrating remarkable effects in > patients with refractory disease. > > One of the study sites for CAL-101 (in patients with relapsed or > refractory CLL) is here in St. Louis (Washington Univ.). Initial > results, after some of these patients have been taken off treatment > with CAL-101, indicate that there is a rapid re-establishment of the > disease pathologies. > > As a result, there is some thinking that these patients (particularly > the refractory patients) will need to continue CAL-101, for the rest > of their lives, or until any side-effects of CAL-101 become too much > of a problem. > > From the context of few current treatment options for refractory > patients, such an option of continued CAL-101 treatment, if > efficacious in maintaining pathologies within a tolerable spectrum, > would seem to be quite a successful outcome from the perspective of > refractory patients. > > It would even seem that it is likely such reduction of potentially > lethal pathologies would 'eventually' enable CAL-101 to demonstrate > overall survival responses in refractory patients. However, if the > FDA expects head-to-head comparisons with an approved CLL drug, I'm > not sure I understand how that demonstration could be 'ethically' > conducted in patients who are refractory to approved drugs. > > Question for Dr. Furman: > Is this type of result (of rapid disease return) after withdrawing > CAL-101 being generally observed in the studies of CAL-101 on > refractory CLL patients? > > Al Janski > Quote Link to comment Share on other sites More sharing options...
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