Vectibix® (Panitumumab) Granted Approval for Expanded Indications in the European Union

Thousand Oaks, California, November 15 (ots/PRNewswire) -

Amgen today announced that the European Commission (EC) has
approved a variation to the marketing authorization for Vectibix(R)
(panitumumab) to include indications for the treatment of patients
with wild-type KRAS metastatic colorectal cancer (mCRC) in first-line
in combination with FOLFOX and in second-line in combination with
FOLFIRI in patients who have received first-line
fluoropyrimidine-based chemotherapy (excluding irinotecan). This
approval of Vectibix applies to all 27 European Union (EU) member
states. Prior to this approval, Vectibix had received conditional
approval in the EU as monotherapy. The monotherapy indication was
also further revised to state that Vectibix is indicated for the
treatment of patients with wild-type KRAS mCRC as monotherapy after
failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens.

Colorectal cancer is the second most common cancer in women
worldwide and the third most common cancer in men. Approximately 1.2
million cases of colorectal cancer are expected to occur globally.
With more than 630,000 deaths worldwide per year, it is the third
leading cause of cancer-related death in the Western world. The
highest incidence rates are found in Japan, North America, parts of
Europe, New Zealand, and Australia, and rates are low in Africa and
Southeast Asia.(1)

"Colorectal cancer can have a devastating impact on the lives of
patients affected by this disease," said Professor Jean-Yves
Douillard, director of Clinical and Translational Research, ICO
Centre R Gauducheau, France. "This European Commission approval for
Vectibix earlier in the treatment continuum marks a welcome and
important addition of treatment choice in an area where few targeted
agents have shown to be effective when used with chemotherapy."

Data from studies 20050203 (PRIME) and 20050181 ('181) showed
that adding Vectibix to either FOLFOX or FOLFIRI chemotherapy
improved progression-free survival (PFS) versus chemotherapy alone
for patients with wild-type KRAS mCRC. Additionally, the overall
response rate (ORR) of Vectibix plus chemotherapy was higher than
chemotherapy alone. Although numerically greater, the improvement in
median overall survival (OS) did not achieve statistical significance
in the Vectibix arm of either trial.(2)(3) The Amgen PRIME and '181
studies were among the first Phase 3 studies to prospectively analyze
the effect of an anti-epidermal growth factor receptor (EGFR)
inhibitor based on KRAS status in patients with mCRC.

Adverse events in the PRIME and '181 studies included known
toxicities associated with EGFR therapy, such as rash, diarrhea, and
hypomagnesemia. The incidence of grade 3/4 infusion reactions in the
treatment arms for the two trials was approximately one percent. In
patients with mutated KRAS tumors, outcomes were inferior for those
receiving Vectibix plus FOLFOX versus FOLFOX alone. Vectibix should
only be used in those patients in whom wild-type KRAS status has been
confirmed.

"Today's decision by the EC to extend the therapeutic indications
for Vectibix marks a promising step forward for those patients facing
an aggressive disease where limited treatment options are available,"
said Willard H. Dere, M.D., senior vice president and international
chief medical officer at Amgen. "This is a significant milestone for
Amgen and highlights our commitment to deliver medicines that make a
real difference to the lives of patients."

Vectibix is already approved and established in more than 40
countries as a monotherapy treatment for patients with wild-type KRAS
mCRC, when standard chemotherapy is no longer effective. In the
United States (U.S.), Vectibix received accelerated approval in
September 2006 as a monotherapy for the treatment of patients with
EGFR-expressing mCRC after disease progression on or following
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens. The use of Vectibix is not recommended in
patients whose tumors have KRAS mutations in codon 12 or 13. In
Russia, Japan and Israel, Vectibix is also approved for use in
combination with chemotherapy for patients with wild-type KRAS mCRC.

About KRAS

Results from studies performed over the last 25 years indicate
that KRAS plays an important role in cell growth regulation. In mCRC,
EGFR transmits signals through a set of intracellular proteins. Upon
reaching the nucleus, these signals instruct the cancer cell to
reproduce and metastasize, leading to cancer progression.(4)
Anti-EGFR antibody therapies work by inhibiting the activation of
EGFR, thereby inhibiting downstream events that lead to malignant
signaling. However, in patients whose tumors harbor a mutated KRAS
gene, the KRAS protein is always turned "on," regardless of whether
the EGFR has been activated or therapeutically inhibited. KRAS
mutations occur in approximately 40 to 50 percent of mCRC
patients.(5)(6)

About Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
mCRC. Vectibix was approved in the U.S. in September 2006 as a single
agent for the treatment of patients with EGFR-expressing mCRC with
disease progression on or following fluoropyrimidine-, oxaliplatin-,
and irinotecan-containing chemotherapy regimens. The effectiveness of
Vectibix as a single agent for the treatment of EGFR-expressing mCRC
is based on PFS. More than half of patients who receive Vectibix
monotherapy respond to treatment with an average six month PFS
benefit. Currently no data are available that demonstrate an
improvement in disease-related symptoms or increased survival with
Vectibix.

Retrospective subset analyses of mCRC trials have not shown a
treatment benefit for Vectibix in patients whose tumors had KRAS
mutations in codon 12 or 13. Use of Vectibix is not recommended for
the treatment of mCRC with these mutations.(7)

Important U.S. Product Safety Information (Monotherapy)

WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS

Dermatologic Toxicity: Dermatologic toxicities occurred in 89
percent of patients and were severe (NCI-CTC grade 3 or higher) in 12
percent of patients receiving Vectibix monotherapy. [See Dosage and
Administration (2.1), Warnings and Precautions (5.1), and Adverse
Reactions (6.1)].

Infusion Reactions: Severe infusion reactions occurred in
approximately one percent of patients. Fatal infusion reactions
occurred in postmarketing experience [See Dosage and Administration
(2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1,
6.3)].

The most common adverse events of Vectibix are skin rash with
variable presentations, hypomagnesemia, paronychia, fatigue,
abdominal pain, nausea, and diarrhea, including diarrhea resulting in
dehydration.

Important European Product Safety Information

- Vectibix has been approved in the European Union for the
treatment of patients with wild-type KRAS metastatic colorectal cancer
(mCRC):
- in first-line in combination with FOLFOX
- in second-line in combination with FOLFIRI for patients who
have received first-line fluoropyrimidine-based chemotherapy
(excluding irinotecan)
- as monotherapy after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.
- Vectibix is contraindicated in patients with a history of
severe or life-threatening hypersensitivity reactions to the product and
in patients with interstitial pneumonitis or pulmonary fibrosis.
Vectibix should not be administered in combination with
oxaliplatin-containing chemotherapy to mCRC patients with mutant KRAS
tumors or for whom KRAS tumor status is unknown.
- Adverse events of special importance associated with Vectibix
and/or EGFR monoclonal antibody therapies include dermatologic-related
reactions, pulmonary complications, electrolyte disturbances,
infusion-related reactions (including rare reports with fatal outcome)
and ocular toxicities. Acute renal failure has been observed in patients
who develop severe diarrhea and dehydration. These events should be
monitored carefully, see Summary of Product Characteristics for
information on appropriate management of these adverse events.
- Vectibix should not be used in combination with IFL chemotherapy
or in combination with bevacizumab containing chemotherapy. For patients
with ECOG 2 performance status, assessment of benefit-risk is
recommended prior to initiation of Vectibix in combination with
chemotherapy for treatment of mCRC.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was one
of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, bone disease
and other serious illnesses. With a deep and broad pipeline of
potential new medicines, Amgen remains committed to advancing science
to dramatically improve people's lives. To learn more about our
pioneering science and our vital medicines, visit
http://www.amgen.com.

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(1) Jemal. Global Cancer Statistics. CA CANCER J CLIN
2011;61:69-90

(2) Douillard, JE et al. Randomized, Phase 3 Study (PRIME) of
Panitumumab with FOLFOX4 versus FOLFOX4 Alone as First-Line Treatment
in Patients With Previously Untreated Metastatic Colorectal Cancer. J
Clin Oncol 28. 2010.

(3) Peeters, M et al. Randomized Phase III Study of Panitumumab
With Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared With
FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic
Colorectal Cancer. J Clin Oncol 28, 2010.

(4) Malumbres, M. and Barbacid, M. RAS oncogenes: the first 30
years. Nature Reviews Cancer. 3:459-65, 2003

(5) Karapentis C, S. Snell, L, E. The Laboratory Assessment of
KRAS Mutation Status in Colorectal Cancer. Asia, Pacific Journal of
Oncology and Hematology. 2010.

(6) Friday BB and Adjei AA. K-ras as a target for cancer therapy.
Biochim. Biophys. Acta 1756: 127-144, 2005

(7) Vectibix (panitumumab) [prescribing information]. Thousand
Oaks, Calif: Amgen; 2011.

ots Originaltext: Amgen Europe GmbH
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