Farrell AT, Goldberg KB, Pazdur R. Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs. Blood. 2017;130(11):1285-1289.

doi:10.1182/blood-2018-02-836916

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ERRATUM| April 19, 2018

Farrell AT, Goldberg KB, Pazdur R. Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs. Blood. 2017;130(11):1285-1289.

Blood (2018) 131 (16): 1875–1876.

https://doi.org/10.1182/blood-2018-02-836916

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 approved	FT*	BTD (since 2012)	AA	Full approval	Priority review designation	Expedited 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 approved	FT*	BTD (since 2012)	AA	Full approval	Priority review designation	Expedited 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.

Farrell AT, Goldberg KB, Pazdur R. Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs. Blood. 2017;130(11):1285-1289.

Contents

Data & Figures

Supplemental data

References

Cited By

Email alerts

ASH Publications

American Society of Hematology

Farrell AT, Goldberg KB, Pazdur R. Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs. Blood. 2017;130(11):1285-1289.

Contents

Data & Figures

Supplemental data

References

Related

Related

Cited By

Email alerts

ASH Publications

American Society of Hematology

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