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FDA Approval of Durvalumab for Bladder Cancer

Robert Dreicer, MD, MS, MACP, FASCO, University of Virginia Cancer Center
Published: Friday, May 05, 2017



Transcript:

Robert Dreicer, MD:
The recent FDA approval of durvalumab is based on a large phase II study that was done in patients who received prior platinum. The data appear very similar to data that were obtained in the nivolumab and the atezolizumab trials. The toxicity profile is very similar. I think the FDA looked at it as another agent in the same class—with very similar activity to agents already approved—with a good safety record. And I think that on that basis, the approval was granted. How this compound will be used in consideration of multiple drugs in space will be a little complicated. When you’re second or third or fourth—even though you may be a very effective drug—physicians may already be geared up to use other agents. But I think that, as additional data come out, there may be selected patients for which a specific therapy may be more appropriate, but it’s too early to say that yet.

The recent rapid approval of multiple checkpoint inhibitors, including both anti–PD-1 and anti-PD-L1 therapies in urothelial cancer, has really been paradigm shifting. Clinicians who have been using these agents now, for over a year after approval, and even in some patients treated on clinical trials, subsets of patients have seen really dramatic responses. Some of these responses are incredibly durable. For a clinician who has been taking care of this disease for a long time, and in an era when we had suboptimal therapeutics, this is a very exciting time. We have a lot of work to do. Most patients don’t respond to these agents, so we need to find ways to identify those who will respond—and, frankly, develop better therapeutics to broaden the benefit to a larger group of patients.

Transcript Edited for Clarity
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Transcript:

Robert Dreicer, MD:
The recent FDA approval of durvalumab is based on a large phase II study that was done in patients who received prior platinum. The data appear very similar to data that were obtained in the nivolumab and the atezolizumab trials. The toxicity profile is very similar. I think the FDA looked at it as another agent in the same class—with very similar activity to agents already approved—with a good safety record. And I think that on that basis, the approval was granted. How this compound will be used in consideration of multiple drugs in space will be a little complicated. When you’re second or third or fourth—even though you may be a very effective drug—physicians may already be geared up to use other agents. But I think that, as additional data come out, there may be selected patients for which a specific therapy may be more appropriate, but it’s too early to say that yet.

The recent rapid approval of multiple checkpoint inhibitors, including both anti–PD-1 and anti-PD-L1 therapies in urothelial cancer, has really been paradigm shifting. Clinicians who have been using these agents now, for over a year after approval, and even in some patients treated on clinical trials, subsets of patients have seen really dramatic responses. Some of these responses are incredibly durable. For a clinician who has been taking care of this disease for a long time, and in an era when we had suboptimal therapeutics, this is a very exciting time. We have a lot of work to do. Most patients don’t respond to these agents, so we need to find ways to identify those who will respond—and, frankly, develop better therapeutics to broaden the benefit to a larger group of patients.

Transcript Edited for Clarity
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