FDA approvals
June 18, 2010
THE US Food and Drug
Administration has approved a new
chemotherapy drug for the treatment
of advanced prostate cancer.
Sanofi-aventis’ Jevtana
(capazitaxel) is used in conjunction
with prednisone, and is the first
treatment for “advanced, hormonerefractory,
prostate cancer that has
worcened during or after treatment
with docetaxel”.
Jevtana was approved in 11
weeks under the FDA’s priority
review program, which allows for
an expedited review period for
drugs which may offer major
advances in treatment, or provide a
treatment where no adequate
therapy exists.
MEANWHILE the FDA has also
approved a new indication for
Novartis’ Tasigna (nilotinib), for the
treatment of rare blood cancer
Philadelphia chromosome positive
chronic phase chronic myeloid
leukaemia (PH+CP-CML) which is a
slowly progressing blood and bone
marrow disease linked to a genetic
abnormality.
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