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Liposomal Doxorubicin and the Accelerated Approval Process

Institute for Cancer Drug Development, Palo Alto, CA

To the Editor:

I would like to comment on Drs Joseph DiMasi and Henry Grabowski's review,¹ published in the January 10, 2007, issue of the Journal of Clinical Oncology.

The authors failed to list Doxil (generically known as doxorubicin; Ortho Biotech Products, Bridgewater, NJ) in Table 1, which presented the new oncology drugs approved in the United States from 1990 to 2005. While this omission may seem trivial, it is not if one considers that Doxil was the first accelerated oncology drug approval and helped usher in an era of rapid drug approvals based on the surrogate marker, tumor response.

Having defended Doxil before the Oncology Drug Advisory Committee leading to its approval, I have become keenly aware of the advantages and disadvantages of the accelerated approval process. As we now know, tumor shrinkage is not always a surrogate for improved survival or quality of life. Another major point overlooked in this review was that many industry sponsors of oncology drugs approved by this process have failed to submit confirmatory, postapproval trials as required under the accelerated approval process. Coupled with the high cost these drugs put on the health care system, many are left to think that commercial companies have abused the opportunity provided by the accelerated approval process. However, as oncologists, we all want promising therapies available for our patients as early as possible. Perhaps we should consider keeping the accelerated approval process available while restricting the reimbursement to the company until randomized, controlled trials showing an effect of survival or quality of life have been conducted. Alternatively, US oncologists must fully support phase III, randomized clinical trials comparing experimental therapies to best supportive care when there are no approved therapies for the indicated patient population.

AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The author indicated no potential conflicts of interest.

REFERENCE

1. DiMasi JA, Grabowski HG: Economics of new oncology drug development. J Clin Oncol 25:209-216, 2007[Abstract/Free Full Text]

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  Joseph A. DiMasi and Henry G. Grabowski
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