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On page 1286 in the 14 September 2017 issue, some of the information about idelalisib in Table 2 is incorrect or missing. The table indicates that idelalisib received full approval from the US Food and Drug Administration for treatment of follicular lymphoma (FL) in 2014. However, it actually received accelerated approval. Some other information about the application for idelalisib for FL was omitted from the table. The corrected Table 2 is shown below. The errors have been corrected in the online version, which now differs from the print version.

Table 2.

2010 to 2016 new molecular entity approved products for hematology using innovative FDA regulatory programs

Regulatory programs/drug approvedFT*BTD (since 2012)AAFull approvalPriority review designationExpedited review†Time from receipt to approval, y
Asparaginase Erwinia Chrysanthemi Yes No No 2011 Yes no 1.05 
Belinostat Yes No 2014  Yes Yes 0.56 
Blinatumomab NA Yes 2014  Yes Yes 0.21 
Bosutinib NA No No 2012 No No 0.80 
Brentuximab Vedotin Yes No 2011 HL 2011 ALCL 2015 Yes Yes 0.47 
Carfilzomib Yes No 2012 2016 No No 0.81 
Daratumumab Yes Yes 2015 2016 Yes Yes 0.36 
Deferiprone Yes No 2011  Yes No 2.70‡ 
Defibrotide sodium Yes No No 2016 Yes No 0.67 
Edoxaban NA No No 2015 No No 1.0 
Elotuzumab NA Yes No 2015 Yes Yes 0.42 
Ibrutinib Yes Yes 2013 MCL  Yes Yes 0.38 
Idelalisib Yes NA No No No 2014 FL 2014 CLL Yes No Yes No 0.63 0.87 
Idarucizumab NA Yes 2015  Yes No 0.66 
Ixazomib NA No No 2015 Yes Yes 0.67 
Obinutuzumab NA Yes No 2013 Yes Yes 0.53 
Omacetaxine Mepesuccinate Yes No 2012 2014 No No 3.13‡ 
Peginesatide No No No 2012 No No 0.84 
Pomalidomide Yes No 2013 2015 No No 0.83 
Ponatinib Yes No 2012 2016 Yes Yes 0.38 
Panobinostat NA No 2015  Yes No 0.92 
Rivaroxaban NA No No 2011 No No 2.92 
Ruxolitinib Yes No No 2011 Yes No 0.45 
Siltuximab NA No No 2014 Yes No 0.65 
tbo-filgrastim NA No No 2012 No No 2.75‡ 
Venetoclax NA Yes 2016  Yes No 0.45 
Regulatory programs/drug approvedFT*BTD (since 2012)AAFull approvalPriority review designationExpedited review†Time from receipt to approval, y
Asparaginase Erwinia Chrysanthemi Yes No No 2011 Yes no 1.05 
Belinostat Yes No 2014  Yes Yes 0.56 
Blinatumomab NA Yes 2014  Yes Yes 0.21 
Bosutinib NA No No 2012 No No 0.80 
Brentuximab Vedotin Yes No 2011 HL 2011 ALCL 2015 Yes Yes 0.47 
Carfilzomib Yes No 2012 2016 No No 0.81 
Daratumumab Yes Yes 2015 2016 Yes Yes 0.36 
Deferiprone Yes No 2011  Yes No 2.70‡ 
Defibrotide sodium Yes No No 2016 Yes No 0.67 
Edoxaban NA No No 2015 No No 1.0 
Elotuzumab NA Yes No 2015 Yes Yes 0.42 
Ibrutinib Yes Yes 2013 MCL  Yes Yes 0.38 
Idelalisib Yes NA No No No 2014 FL 2014 CLL Yes No Yes No 0.63 0.87 
Idarucizumab NA Yes 2015  Yes No 0.66 
Ixazomib NA No No 2015 Yes Yes 0.67 
Obinutuzumab NA Yes No 2013 Yes Yes 0.53 
Omacetaxine Mepesuccinate Yes No 2012 2014 No No 3.13‡ 
Peginesatide No No No 2012 No No 0.84 
Pomalidomide Yes No 2013 2015 No No 0.83 
Ponatinib Yes No 2012 2016 Yes Yes 0.38 
Panobinostat NA No 2015  Yes No 0.92 
Rivaroxaban NA No No 2011 No No 2.92 
Ruxolitinib Yes No No 2011 Yes No 0.45 
Siltuximab NA No No 2014 Yes No 0.65 
tbo-filgrastim NA No No 2012 No No 2.75‡ 
Venetoclax NA Yes 2016  Yes No 0.45 

ALCL, anaplastic large-cell lymphoma; CLL, chronic lymphocytic leukemia; FL, follicular lymphoma; HL, Hodgkin lymphoma; MCL, mantle cell lymphoma; NA, not available.

*

The FDA cannot release this information unless the company releases the information.

†

Faster than the priority review clock.

‡

Complexities arose during review requiring more than 1 submission.

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