Vectibix (panitumumab)

http://www.medscape.com/viewarticle/545246
FDA Approves Amgen Colon Cancer Drug Vectibix

By Deena Beasley and Bill Berkrot

LOS ANGELES/NEW YORK (Reuters) Sept 28 - The U.S. Food and Drug
Administration said on Wednesday it had approved Amgen Inc.'s drug
Vectibix (panitumumab) for use in colon cancer patients whose tumors have
spread despite chemotherapy.

The drug, which works by blocking epidermal growth factor, is expected to
compete with Erbitux (cetuximab) from ImClone Systems Inc. It received
accelerated approval from the FDA after showing effectiveness in slowing
tumor growth and, in some cases, reducing the size of the tumor.

Amgen said Vectibix will be on the market in early to mid-October and will
be priced about 20% below Erbitux, or about $8,000 a month.

An Amgen spokeswoman said the company expects to report in January
preliminary results from trial of Vectibix as an initial treatment for
colon cancer.

The company also announced a financial assistance program for patients who
are uninsured, underinsured, or unable to afford their insurance
co-payments.

"This approval adds a treatment option for patients with an advanced stage
of a disease that can be life-threatening," Dr. Steven Galson, director of
FDA's Center for Drug Evaluation and Research, said in a statement.

A pivotal-stage trial showed that patients treated with Vectibix showed a
better-than-expected 46% decrease in the rate of tumor growth versus those
who received supportive care.

As part of the approval, Amgen committed to conduct a post-marketing trial
to show whether the drug lengthens survival in patients with fewer prior
chemotherapies, the FDA said.

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http://www.fda.gov/bbs/topics/NEWS/2006/NEW01468.html

FOR IMMEDIATE RELEASE
P06-148
September 27, 2006


Media Inquiries:
Megan Moynahan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves a New Drug for Colorectal Cancer, Vectibix

The Food and Drug Administration (FDA) today approved Vectibix
(panitumumab) for the treatment of patients with colorectal cancer that
has metastasized (spread to other parts of the body) following standard
chemotherapy. Vectibix, a monoclonal antibody that binds to a protein
called epidermal growth factor receptor or EGFR on some cancer cells,
received an accelerated approval after showing effectiveness in slowing
tumor growth and, in some cases, reducing the size of the tumor.

In the United States, it is estimated that 150,000 new cases of colon
cancer will be diagnosed and 55,000 deaths will occur from colon and
rectal cancer in 2006. Approximately 70 percent of all colorectal
carcinomas test positive for EGFR.

?Colorectal cancer is the third most common cancer and the third leading
cause of cancer mortality in the United States,? said Dr. Steven Galson,
director of FDA?s Center for Drug Evaluation and Research. ?This approval
adds a treatment option for patients with an advanced stage of a disease
that can be life-threatening.?

FDA approved Vectibix on the basis of the results of a randomized,
controlled clinical trial of 463 patients with metastatic cancer of the
colon and the rectum after undergoing treatment with chemotherapy drugs,
fluoropyrimidine, oxaliplatin and irinotecan.

The mean time to disease progression or death in patients receiving
Vectibix was 96 days versus 60 days in patients receiving the best
standard supportive care. In addition, 8 percent of the patients on
Vectibix experienced a tumor shrinkage that in some cases exceeded 50
percent of the pre-treatment size of the tumor. Both study groups showed
similar overall survival.

Under the accelerated approval program, drugs for serious and
life-threatening diseases can be made available earlier in the development
process if a promising effect of the drug is observed. As part of the
approval, the manufacturer of Vectibix committed to conduct a
postmarketing trial to show whether the drug improves patients? survival
in patients with fewer prior chemotherapies.

The most serious adverse events in the studies of Vectibix included
pulmonary fibrosis, severe skin rash complicated by infections, infusion
reactions, abdominal pain, nausea, vomiting and constipation. The most
common adverse events associated with the drug included skin rash,
fatigue, abdominal pain, nausea, and diarrhea.

Vectibix is manufactured by Amgen Inc. in Thousand Oaks, California.
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http://www.medicalnewstoday.com/medicalnews.php?newsid=23626
Metastatic Colorectal Cancer - Phase 3 Clinical Trial of Panitumumab
Therapy for First-Line Treatment
Main Category: Cancer / Oncology News
Article Date: 30 Apr 2005 - 10:00am (PDT)

Amgen Inc (Nasdaq:AMGN) and Abgenix, Inc (Nasdaq:ABGX) today announced the
initiation of a Phase 3 clinical study to evaluate the potential benefits
of adding panitumumab, an experimental fully human monoclonal antibody,
administered every other week to bevacizumab (Avastin(TM), Genentech) and
either oxaliplatin- (Eloxatin(R), sanofi-aventis) or irinotecan-based
(Camptosar(R), Pfizer) chemotherapy for the first-line treatment of
metastatic colorectal cancer. The clinical trial, called the PACCE
(Panitumumab Advanced Colorectal Cancer Evaluation) study, is a
randomized, multi-center, open-label study, with endpoints of
progression-free survival, overall survival and response rate. Enrollment
in the study of approximately 1,000 patients is already underway.

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http://www.clinicaltrials.gov/ct/show/NCT00115765
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
This study is currently recruiting patients. (see web page for locations)
The purpose of this study is to assess whether treatment with the study
drug, panitumumab given concomitantly with every 2 (Q2) week
oxaliplatin-based chemotherapy and bevacizumab improves progression-free
survival (PFS) compared to treatment with Q2-week oxaliplatin-based
chemotherapy and bevacizumab alone. All subjects will receive Q2-week
oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. Control arm
subjects will not receive concomitant panitumumab therapy.

tudy Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel
Assignment

Official Title: PACCE: A Randomized, Open-Label, Controlled, Clinical
Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the
First-Line Treatment of Subjects With Metastatic Colorectal Cancer

Study chairs or principal investigators MD, Study Director, Amgen

More Information AmgenTrials clinical trials website
Study ID Numbers: 20040249
Last Updated: September 28, 2006
Record first received: June 26, 2005
ClinicalTrials.gov Identifier: NCT00115765

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