Colon Cancer Drugs Erbitux and Vectibix May Require Gene Screening

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An FDA advisory panel is scheduled to meet today to review whether the drug labels for Erbitux and Vectibix, which are used to treat colon cancer, should indicate that patients be screened for the KRAS gene mutation, as the costly drugs do not work in people with the gene mutations.

Erbitux (cetuximab) and Vectibix (panitumumab) are epidermal growth factor (EGFR) protein inhibitors. They interfere with signals in cancer cells that cause them to grow, divide and proliferate. However, for individuals with KRAS mutations, research has established that the drugs do not work.

Erbitux and Vectibix can cost between $8,000 and $10,000 a month, and use of the drugs by individuals with the gene mutations not only causes unnecessary expense, but also exposes individuals to potentially serious side effects, such as severe skin reactions.

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Last year, Erbitux, which was introduced by Eli Lilly & Co’s ImClone in 2004, generated sales of $1.3 billion and Vectibix, which was introduced by Amgen, Inc. in 2006, generated sales of $170 million.

The KRAS gene mutation is present in about 40% of people with colon cancer, and the drug makers are likely to experience a drop in sales if they are required to indicate patients should be screened for the gene mutation. However, a growing number of experts have called for the screening, as the drugs should not be used in those with no chance of benefits.

KRAS screening tests are readily available, involving analysis a sample of tissue from a tumor.

The FDA panel of independent advisors will meet on December 16, 2008 to review the data and make a recommendation to the FDA about whether the drug makers should be forced to update the prescribing information to advise patients that the treatment will not work if they carry the genes.

Although the FDA is not required to follow the recommendations of their advisory panels, they usually do.

Tags: Cancer, Colon Cancer, Erbitux, Vectibix
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11 Comments

Ruby
My husband was using Erbitux for his colon cancer. He passed away in 2006. He was stage 4 colon cancer. His doctor at first said there was nothing to do. Then he used this drug. I feel like they should have left him alone. We cashed in 401k and life insurance for this plus what ever the insurance paid. It would be nice to recoop some of this cost. Since he died without any relief.
Katherine
Dec. 22, 2015, my dad had an Erbitux treatment and had an allergic reaction. I thought he was going to die in front of us. It caused him to have a stroke which impaired his vision. We need help. What do we do? He was self-sufficient before…now he can’t fix his own meals. Any advice?
Fritzie O
My husband’s oncologist changed his chemo meds to vectibix . The doctor advised us that the worst side effect is similar to that of a teenage acne or dryness of skin. After 5 days, my husband’s face was full of acne with pus , it got worst and despite of the antibiotics and lotion that was prescribed his face has more acne , back of ears , chest area and the back. My husband suffered sleepless nights from the pain caused by this acne. Embarrassment when he is around people looking and thinking that he had an infectious disease. The doctor should have done further tests
Laura
Hopefully one day someone will make doctors test patients before giving them Erbitux. It is such a SIMPLE and INEXPENSIVE test. But if they test first look how much MONEY the drug company would lose. It is all about the $$$$$$. They KNOW it is a tick bite that causes the infusion reaction. It has been proven – they know but they CHOOSE not to tell.. Legal murder.
Nadia
My dad died on the 26th November 2013 after receiving his first dose of Cetuximab. My mum tells me the infusion was only in him for a few mins and he suffered a cardiac arrest. Obviously we are utterly devastated and find it hard to believe something supposed to save your life can take it away so suddenly. There was no mention of a fatal reaction in the information given before he started treatment and in fact i looked it up on the internet and found only great things. Since his passing ive found out about the link between tick bites and a natural IGE antibody. Could a simple blood test not have detected this antibody?????? My dad had suffered infections over the years due to mosquitos bites from holidays in his native country of Italy but they were all controllled years gone by at the time of his death. I wonder if these infections contributed in some way? We live in Scotland so ticks are not unusual but dad never complained of any such thing. Desperate for some answers ;-(
Laura
My husband had an immediate and severe allergic reaction to his first cetuximab (erbitux) infusion that caused his death on Oct 22, 2013. We live in Australia. He worked outside and got bitten by many things over the years. They did not test for antibody prior to treatment. No one mentioned the prospect of a severe allergic reaction although it was buried in the reams of information given to us. How many others are out there?
Laura
Brian – basically the same thing happened to my husband two months ago only he died within minutes of receiving Erbitux. Anaphylaxis is a very low percentage UNLESS you live in the Southeast United States (the HSR belt). The percentage then can be as high as 22%-25% (your father must have spent some time in the southeast maybe hiking or camping)!! Mandatory testing should be enforced not only for KRAS but they should also have to test for Ige antibodies, which they can. And yes, all we were told about is the “teenage acne”. Their ONC’s must have had the same drug sales rep.
R.Kemal Derin
I had been operated from colon cancer and hepatic multiple metastasis 5 years ago .6 months ago Erbitux was started to given to me with FOLFฤฐRฤฐ.Because it was found that I had negative K RAS mutation. After 4 months,I had left achille tendonopathy. ฤฐn MR ,TEHRE WAS A LฤฐTTLE TENDON RUPTURE. With consevative therapy now I am well. I am an Internist doctor.
Brian
My father had cancer and was told the worst side affect of this drug might be teenage acne. After 5-15 minutes of the drug being administered into him he started itching and his tongue was swelled up. The swelling cut off his airway and by the time he got help he was already brain dead do to the lack of oxygen. The problem I see is they say it’s a very low percentage of this problem with the drug but I know of another person that experianced the same problem but luckily they stopped the transfusion. This should not have happened
VICKIE
NONE OF THE SHIT WORKS. IT ONLY SCREW YOUR BODY UP WORSE. MY HUSBAND WAS DIAGNOSED AND SENT HOME AFTER THREE TREATMENTS OF ERIBITUX AND ONE TREATMENT OF VECTIBIX.
Kim
My husband has been taking vectibix and for the first 4 treatments we saw a significant drop in his tumor marker. Then, it started to reverse until it was determined that it wasn’t working anymore. His oncologist wanted to try Erbitux next, but the insurance company refuses to pay for this drug because of link to vectibix. We are very upset that the insurance company is making the decision that my husband can no longer receive any treatment for his colon cancer.

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