Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)
July 17 2009 - 6:10PM
PR Newswire (US)
Class Labeling Recognizes KRAS as a Predictive Biomarker for
anti-EGFr Antibody Monotherapy in Metastatic Colorectal Cancer
Results from First Pivotal Trials Prospectively Evaluating KRAS
Utility in Combination Therapy Expected In Third Quarter 2009
THOUSAND OAKS, Calif., July 17 /PRNewswire-FirstCall/ -- Amgen Inc.
(NASDAQ:AMGN) today announced the U.S. Food and Drug Administration
(FDA) has approved revisions to the U.S. prescribing information
for the epidermal growth factor receptor (EGFr) class of
antibodies, including Vectibix (panitumumab). This decision follows
the FDA's December 2008 Oncologics Drugs Advisory Committee (ODAC)
meeting where the clinical utility of the KRAS gene as a predictive
biomarker in patients with metastatic colorectal cancer (mCRC)
treated with anti-EGFr antibody was discussed. "We are pleased that
the FDA has recognized the clinical importance of KRAS as a
predictive biomarker for anti-EGFr antibody therapy," said Sean
Harper, M.D., chief medical officer and head of Global Development
at Amgen. The INDICATION AND USAGE section of the prescribing
information has been updated to include that retrospective subset
analyses of metastatic colorectal cancer 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 colorectal cancer with these mutations. The
CLINICAL STUDIES section of the prescribing information has been
updated to reflect results from retrospective analyses across seven
randomized clinical trials with agents in this class. This includes
the first Phase 3 analysis that showed mCRC patients with mutated
KRAS tumors do not respond to monotherapy with an EGFr-inhibiting
antibody (the Vectibix "408" trial). "With this label update,
physicians can now eliminate anti-EGFr antibodies as a treatment
option for patients with mutated KRAS tumors and redirect those
patients to alternative therapies, avoiding unnecessary treatments
in patients who are unlikely to benefit," said Sean Harper. This
label update is specific to the utility of KRAS as a biomarker for
Vectibix used as a monotherapy. In the combination chemotherapy
setting, the Vectibix "181" and "PRIME (203)" trials will be the
first prospective Phase 3 clinical studies testing the clinical
utility of KRAS as a predictive biomarker in mCRC patients in
earlier lines of therapy. Data from the "181" and "PRIME (203)"
trials are expected in the third quarter of 2009. This update
follows recent KRAS related action from key cancer organizations,
including the American Society of Clinical Oncology (ASCO) and the
National Comprehensive Cancer Network (NCCN). A Clinical
Provisional Opinion (CPO) was issued by ASCO in January, where the
organization recommended the use of the KRAS biomarker in selecting
the appropriate patients for anti-EGFr antibody therapy. In
November 2008, the NCCN announced updates to their Guidelines on
Colon and Rectal Cancers. The guideline updates included the
recommendation that a determination of the KRAS gene status of
either the primary tumor or a site of metastasis should be part of
the pre-treatment work-up for patients diagnosed with metastatic
colorectal cancer. About Colorectal Cancer Colorectal cancer is the
third most common cancer diagnosed in men and in women in the
United States (U.S.). The American Cancer Society estimates that
about 106,100 new cases of colon cancer and 40,870 new cases of
rectal cancer will be diagnosed in 2009. Colorectal cancer is the
second leading cause of cancer death among men and women in the
U.S. and it has been estimated that more than 49,000 people will
die from colorectal cancer in 2009. That means that one person in
the U.S. dies of colorectal cancer every 9.3 minutes. About
Vectibix Vectibix is indicated as a single agent for the treatment
of patients with epidermal growth factor receptor (EGFr)-
expressing metastatic colorectal carcinoma after 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,
metastatic colorectal carcinoma is based on progression-free
survival. Currently no data demonstrate an improvement in
disease-related symptoms or increased survival with Vectibix.
Important Product Safety Information Dermatologic Toxicity:
Dermatologic toxicities occurred in 89 percent of patients and were
severe (NCI-CTC grade 3 and higher) in 12 percent of patients
receiving Vectibix monotherapy. Withhold Vectibix for dermatologic
toxicities that are grade 3 or higher or are considered
intolerable. If toxicity does not improve to less than or equal to
grade 2 within 1 month, permanently discontinue Vectibix. The
clinical manifestations included, but were not limited to,
dermatitis acneiform, pruritus, erythema, rash, skin exfoliation,
paronychia, dry skin, and skin fissures. Subsequent to the
development of severe dermatologic toxicities, infectious
complications, including sepsis, septic death, and abscesses
requiring incisions and drainage were reported. Infusion Reactions:
Severe infusion reactions occurred in approximately 1 percent of
patients. Severe infusion reactions included anaphylactic
reactions, bronchospasm, and hypotension. Although not reported
with Vectibix, fatal infusion reactions have occurred with other
monoclonal antibody products. Stop infusion if a severe infusion
reaction occurs. Depending on the severity and/or persistence of
the reaction, permanently discontinue Vectibix. About Amgen Amgen
discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of
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bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
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discussed in this news release. CONTACT: Amgen, Thousand Oaks
Christine Regan: 805-447-5476 (media) Arvind Sood: 805-447-1060
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