By John Revill
ZURICH--Swiss pharmaceuticals giant Novartis AG (NOVN.VX) said
the U.S. Food and Drug Administration had approved the use of one
of its cancer medications to treat multiple myeloma, an aggressive
form of blood cancer.
Basel-based Novartis said the FDA approved the use of Farydak in
combination with Takeda Pharmaceutical Co.'s (4502.TO) Velcade and
dexamethasone, an anti-inflammatory, after a patient has received
at least two prior treatment regimens of Velcade and an
immunomodulatory drug.
The approval was based on clinical trial results that showed the
combination almost doubled the amount of time patients experienced
no worsening of their disease to 10.6 months compared to standard
treatments. Just under 60% of the patients also saw their cancer
shrink or disappear, better than the 41% for other patients.
The FDA's decision overturned advice from a panel of medical
experts who last year voted against recommending the combination's
approval, saying its side effects, such as severe diarrhea and
heart problems, outweighed its potential benefits. The FDA usually
follows the advice of advisory panels but is not obligated to do
so.
Farydak is the first in a new class of treatments called HDAC
inhibitors designed to restore cell function for patients with
multiple myeloma, a cancer of plasma cells found in the bone
marrow.
The condition affects as many as five out of every 100,000
people globally. Almost 22,000 Americans are diagnosed with the
cancer every year, and around 11,000 die from it, according to the
National Cancer Institute.
Novartis said regulatory submissions for Farydak are being
reviewed by health authorities worldwide, with applications
underway in the European Union and Japan.
Write to John Revill at John.Revill@wsj.com
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