Vectibix(TM) (panitumumab) Receives Positive Opinion for Marketing Authorization in the European Union
Opinion Based on Positive Benefit / Risk Assessment in Patients with Metastatic Colorectal Cancer with Non-Mutated KRAS
Amgen (NASDAQ:AMGN) today announced that the European Committee
for Medicinal Products for Human Use (CHMP) has issued a positive
opinion recommending a conditional marketing authorization for
Vectibix(TM) (panitumumab) in the European Union (EU) for patients
with refractory metastatic colorectal cancer with non-mutated
(wild-type) KRAS genes.
"We are pleased that Vectibix has received a positive opinion for
conditional approval so patients in the EU have further treatment
options for metastatic colorectal cancer," said Willard Dere, M.D.,
senior vice president and international chief medical officer at
Amgen. "This is an important step forward in personalized cancer care.
Amgen is committed to discovering, validating and implementing novel
clinically relevant biomarkers to help physicians provide the right
treatment for patients."
The CHMP positive opinion for Vectibix is based on a positive
benefit / risk assessment in a patient population that currently has
few treatment options available to them. As part of the CHMP review,
clinical data supporting the utility of KRAS mutation status as a
biomarker for clinical outcome were provided. These data were
evaluated in combination with the overall clinical benefit observed in
the pivotal "408" study and safety database available. The KRAS data
will be presented for the first time at the 14th European Cancer
Conference, Barcelona, on September 25th in the Presidential
Symposium.
KRAS plays an important role in cell growth regulation and
oncogenesis. Anti-epidermal growth factor receptor (EGFR) therapies
work by blocking the activation of EGFR, thereby inhibiting downstream
events that lead to malignant signaling. However, in patients with
tumors harboring a mutated or activated KRAS, the KRAS protein is
always turned "on" regardless of whether EGFR has been activated or
therapeutically inhibited. Thus, in patients with mutated KRAS,
signaling continues despite anti-EGFR therapy. Mutant KRAS is detected
in approximately 40 percent of mCRC.
About Vectibix
Vectibix (panitumumab) the first fully human IgG2 monoclonal
antibody (MAb), targets the epidermal growth factor receptor (EGFr), a
protein that plays an important role in cancer cell signalling. With
its demonstrated efficacy, low rate of infusion reactions and
immunogenicity, and convenient Q2W dosing schedule Vectibix provides
an important option in the management of metastatic CRC patients.
Ongoing Phase 3 trials are exploring the potential of administering
Vectibix in combination with chemotherapy for first- and second-line
mCRC.
Approved by the FDA in September 2006 Vectibix is indicated for
the treatment of patients with epidermal growth factor receptor (EGFr)
expressing metastatic colorectal cancer after disease progression on,
or following fluoropyrimidine, oxaliplatin and irinotecan containing
chemotherapy regimens. The effectiveness of Vectibix for the treatment
of metastatic colorectal carcinoma is based on progression-free
survival. Currently no data are available that demonstrate an
improvement in disease related symptoms or increased survival with
Vectibix.
In the EU, Vectibix is indicated as monotherapy for the treatment
of patients with metastatic colorectal carcinoma expressing EGFR with
non-mutated KRAS tumours and after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Important Product Safety Information - U.S.
Dermatologic toxicities, related to Vectibix blockade of EGF
binding and subsequent inhibition of EGF receptor-mediated signalling
pathways, included but were not limited to dermatitis acneiform,
pruritus, erythema, rash, skin exfoliation, paronychia, dry skin and
skin fissures. Dermatologic toxicities were reported in 89 percent of
patients treated with Vectibix and were severe in 12 percent of
patients. Severe dermatologic toxicities were complicated by
infection, including sepsis, septic death and abscesses requiring
incisions and drainage. Vectibix may need to be withheld or
discontinued for severe dermatologic toxicities.
Severe infusion reactions occurred with Vectibix in approximately
one percent of patients. Severe infusion reactions were identified as
anaphylactic reactions, bronchospasm, fever, chills and hypotension.
Although fatal infusion reactions have not been reported with
Vectibix, they have occurred with other monoclonal antibody products.
Severe infusion reactions require stopping the infusion and possibly
permanently discontinuing Vectibix, depending on the severity and / or
persistence of the reaction.
About Amgen
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realise the new science's promise by bringing safe,
effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics has changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, 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 www.amgen.com.
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