As oncology drug after oncology drug fails to achieve accelerated approval, sponsors are seeking other ways to speed trials. Malorye Allison investigates.
Change history
09 February 2011
In the version of the article originally published, it was stated that “Avastin was studied in combination with Taxol in all these trials, and compared to Taxol alone.” It should have read. “Avastin was studied in combination with chemotherapy.”In addition, it stated that the FDA had rescinded approval of Avastin for metastatic breast cancer. It should have read, the FDA “recommended removal of the breast cancer indication from the Avastin label…” The errors have been corrected in the HMTL and PDF versions of the article.
References
Allison, M. Nat. Biotechnol. 28, 879–880 (2010).
Merrill, J. The Pink Sheet Daily, Elsevier Business Intelligence, 27 August 2010.
Vogel, C.L. et al. J. Clin. Oncol. 27 Supplement, 1017 (2009).
Mulcahy, N. Medscape Today, <http://www.medscape.com/viewarticle/703912> 4 June 2009.
Bollag, G. et al. Nature 467, 596–599 (2010).
Harmon, A. The New York Times, p. 1, 18 September 2010.
Soda, M. et al. Nature 448, 561–566 (2007).
Anonymous. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products (FDA, March 2004). <http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm>
Anonymous. Qualification Process for Drug Development Tools. Draft Guidance (US Department of Health and Human Services, FDA, CDER, October 2010). <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf>
Allison, M. Nat. Biotechnol. 28, 383–384 (2010).
Richey, E.A. et al. J. Clin. Oncol. 27, 4398–4405 (2009).
Lanthier, M. & Sridhara, R. J. Clin. Oncol. 28, e226 (2010).
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Allison, M. Can cancer clinical trials be fixed?. Nat Biotechnol 29, 13–15 (2011). https://doi.org/10.1038/nbt.1746
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DOI: https://doi.org/10.1038/nbt.1746
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