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Carfilzomib Granted
Priority Review in
Relapsed Multiple
Myeloma
The U.S. Food and Drug Administration granted priority review status to the
supplemental new drug application for
carfilzomib for the treatment of patients
with relapsed multiple myeloma who
have received at least one prior therapy.
The FDA set a target action date of July
26, 2015. Priority review is assigned to
applications for drugs that treat serious conditions and would, if approved,
provide significant improvements in the
safety or effectiveness of the treatment,
diagnosis, or prevention of serious conditions. This decision was based on results
from the phase 3 international, randomized ASPIRE trial – first presented at the
2014 ASH Annual Meeting and subsequently published in The New England
Journal of Medicine – and other relevant
data. Currently, carfilzomib is approved
for the treatment of patients with multiple
myeloma who have receiv Y]X\