Article preview from The RPM Report 08/01/2009
Development time is the same for cancer drugs cleared under subpart H and under the regular approval pathway, according to a study in the Journal of Clinical Oncology. Article calls attention to idea that cancer drugs may need new, more favorable FDA policies on surrogate markers. Read on...
Article preview from The RPM Report 08/01/2009
The accelerated approval process has not succeeded in reducing development time of new oncology drugs, according to a study published in the Journal of Clinical Oncology.
Median development times for new molecular entities with accelerated approval was 7.3 years in the period from May 1995, when the first cancer use was cleared under AA regulations, through 2008. Mean development time for regular-approval oncology NMEs in that period: 7.2 years.
Accelerated approval oncology NMEs "are safe and effective, although development times are not accelerated," the authors emphasized. The study, "Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?," was first published online July 27, 2009.
"We conclude that the promise of AA (i.e., shortening the time to approval and decreasing the resource burden of novel cancer drugs) is not being met," authors Charles Bennett (Northwestern University's Feinberg School of Medicine) et al. declare, pointing to the similar development times for AA and regular approval oncology NMEs.
The study validates a common theme raised by oncology product developers and their investors—and among those likely to agree with the findings is the architect of the accelerated approval regulations, former Food & Drug Administration Commissioner David Kessler. Kessler has been advising the Obama Administration to look towards creating a better pathway that would truly accelerate cancer drug development.
A 15-Year Old Process
Accelerated approval was established in 1992 to speed new therapies "for life-threatening diseases" to patients by "allowing sponsors to begin marketing relevant drugs on the basis of trials that identify improvements in surrogate outcomes, such as response rate or progression-free survival, that are reasonably likely to predict clinical benefit." Sponsors are required to confirm the drug's benefit in future clinical trials. The program initially focused on HIV; AA regs were not specifically applied to oncologics until 1996 as part of the Clinton/Kessler era "Reinventing the Regulation of Cancer Drugs" initiative.
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