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News in Brief

By the Numbers: New Biologic License Application Filings and Drug Approvals, 2007–2016

DOI: 10.1158/2159-8290.CD-NB2017-003 Published February 2017
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In 2016, the FDA's Center for Drug Evaluation and Research approved 22 novel drugs, down from 45 in 2015 and below the average of about 29 drugs per year over the last decade. One reason for the decline, according to the FDA, is that five drugs were greenlighted in 2015, ahead of the 2016 dates that had been set for a decision.

The number of novel drugs for cancer treatment authorized by the FDA in 2016 also dropped, from 14 in 2015 to four. However, the agency did approve two diagnostic imaging agents and new indications for already approved therapies, such as the PD-1 inhibitors nivolumab (Opdivo; Bristol-Myers Squibb) and pembrolizumab (Keytruda; Merck). [Source: FDA]

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For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.

  • ©2017 American Association for Cancer Research.
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Cancer Discovery: 7 (2)
February 2017
Volume 7, Issue 2
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By the Numbers: New Biologic License Application Filings and Drug Approvals, 2007–2016
Cancer Discov February 1 2017 (7) (2) 121; DOI: 10.1158/2159-8290.CD-NB2017-003

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By the Numbers: New Biologic License Application Filings and Drug Approvals, 2007–2016
Cancer Discov February 1 2017 (7) (2) 121; DOI: 10.1158/2159-8290.CD-NB2017-003
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