Colon cancer

Colon, or colorectal, cancer is cancer
that starts in the large intestine (colon)
or the rectum (end of the colon).

In 2011 Amgen prevailed in an appeal
to the FDA about extending the
marketing authorization of mAb-based
drug Vectibix to include combination
with chemotherapy for the treatment of
patients with wild-type KRAS metastatic
colorectal cancer (mCRC).

Previously, Vectibix had received
conditional approval in the EU as
monotherapy, which was revised to
state that the drug was indicated for
wild-type KRAS mCRC as
monotherapy after failure of
fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy

In November 2011, EC changed the
marketing authorization to first-line
treatment of wild-type KRAS mCRC in
combination with FOLFOX and as a
second-line therapy in combination
with FOLFIRI in patients who have
received first-line
fluoropyrimidine-based chemotherapy
(excluding irinotecan).

The expanded European indication
should further boost Vectibix sales
outside the U.S. According to Amgen,
Vectibix sales rose 12% in 2011 to
$322 million from $288 million. U.S.
sales rose 6% from 2010 to $122
million in 2011.

Vectibix first entered the U.S. market in

Amgen  is still under FDA review where
Vectibix is concerned, however, on its
first- and second-line mCRC sBLA,
originally filed in late 2010. On July 29
2011, Amgen received a complete
response letter from the FDA seeking
an updated safety analysis and
additional analyses of the overall
survival data in two studies using more
mature datasets. At the time FDA also
said that it would grant approval for the
first- and second-line indications
contingent upon approval of a
companion KRAS diagnostic device,
which is already under development
with Qiagen.

Colonring by Niti Surgical using nitinol
metal rings instead of staples.
The ColonRing is a medical device that
helps the body heal after colon
surgery. The surgeon places the
ColonRing so that it reconnects the
two parts of the colon after the
surgery. Inside the body, the
ColonRing applies gentle pressure to
the sections of the colon until they
completely and naturally grow back
together. This usually takes about 7 to
10 days. After healing is complete, the
ColonRing is expelled from the body,
leaving nothing but healthy tissue.
Before the ColonRing,  surgeons
usually reconnected the colon using
surgical staples. Staples crush and
puncture tissue and can lead to a
number of problems. They stay in the
body permanently. In addition, the
colon often becomes narrower at the
area that has been stapled.

SIR-Spheres, a form of microsphere, is
used for cancers of other body sites
which have spread to the liver.
SIR-Spheres are FDA approved for
patients with colon cancer and are
under investigation for patients with  
cancers of other sites.