Article preview from The RPM Report August 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 August 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.
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