[Ip-health] Some data on oncology drugs approved by the FDA from 2005 to 2015

Jamie Love james.love at keionline.org
Tue Nov 18 04:51:30 PST 2014


Elizabeth Rajasingh and Claire Cassedy have complied some data on the all
of the new oncology drugs (NMEs and BLA) approved by the FDA from 2005
through the present.

There were 49 drugs.  Of the 49, Rajasingh was able to calculate compete
counts on the number of patients in clinical trials cited in the FDA
medical review, for 42 drugs.  For another 7 drugs she has most, but not
all patients.   The average and median size of the trials for the cancer
drugs are much smaller than is the case for all drugs approved by the FDA.
For the 42 drugs with complete data, the average and median number of
patients in trials cited in the FDA medical review were 1173 and 993
patients.   For all 49 drugs, including the 7 with incomplete data, the
average and the median were 1,582 and  1,125, respectively.   To compare,
in 2010, the average and median for all drug approvals were 5224 and 2655.
  Since oncology products have much smaller trials than is the case for all
drugs, the averages for other drugs are not going to be useful in
inferring costs
for cancer drugs.

Rajasingh and Cassedy also were able to identify which of the 49 drugs were
approved as orphan products, and which have received subsequent approval
for an orphan designation.  Of the 49 drugs, 28 (57 percent) were first
approved for an orphan indication, and 38 (77 percent) have received at
least one orphan designation, since approval.  A total of 67 orphan
designations have been received for the 49 drugs, in all.    The Orphan
designation qualifies a drug developer for a tax credit equal to 50 percent
of the cost of the qualifying clinical trials.

http://www.keionline.org/node/2125

-------------

patients in trials cited in Medical Review | Brand Name | Orphan status |
Approval Year


190 ARRANON Orphan 2005
1233 NEXAVAR Orphan 2005
1048 REVLIMID Orphan 2005
795 SUTENT Not yet 2006
1333 SPRYCEL Orphan 2006
1798 VECTIBIX Not yet 2006
349 ZOLINZA Orphan 2006
880 TYKERB Unapproved 2007
1328 TORISEL Orphan 2007
2298 IXEMPRA KIT Not yet 2007
351 TASIGNA Orphan 2007
1351 TREANDA Orphan 2008
251 ADREVIEW Orphan 2008
1472 MOZOBIL Orphan 2008
1954 FIRMAGON Not yet 2008
566 AFINITOR Later 2009
752 FOLOTYN Orphan 2009
2012 VOTRIENT Later 2009
648 ARZERRA Orphan 2009
746 ISTODAX Orphan 2009
14864 PROLIA/XGEVA Later 2010
591 JEVTANA KIT Not yet 2010
2440 HALAVEN Unapproved 2010
2022 YERVOY Orphan 2011
1863 CAPRELSA Orphan 2011
1420 ZYTIGA Not yet 2011
608 ZELBORAF Orphan 2011
357 ADCETRIS Orphan 2011
813 XALKORI 1 2011
902 ERWINAZE Orphan 2011
937 INLYTA Designated/Withdrawn 2012
419 ERIVEDGE Not yet 2012
1870 PERJETA Unapproved 2012
768 KYPROLIS Orphan 2012
6848 ZALTRAP Not yet 2012
1399 XTANDI Not yet 2012
1125 BOSULIF Orphan 2012
176 CHOLINE C-11 Not yet 2012
1264 STIVARGA Later 2012
207 SYNRIBO Orphan 2012
461 COMETRIQ Orphan 2012
583 ICLUSIG Orphan 2012
514 POMALYST Orphan 2013
1317 KADCYLA Unapproved 2013
2798 XOFIGO Not yet 2013
3470 GILOTRIF Orphan 2013
1262 GAZYVA Orphan 2013
3284 IMBRUVICA Orphan 2013
1577 KEYTRUDA Orphan 2014

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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