This page is about a new biological therapy cancer drug called vismodegib. There is information about
Vismodegib (pronounced vis-mod-ee-geeb) is also known by its brand name Erivedge and by the number GDC-0449. It is a new biological therapy drug that researchers are testing. Most of the research so far has tested it for advanced basal cell skin cancers. These are basal cell skin cancers that
- Have spread to another part of the body
- Have come back after surgery and cannot be removed
- Are in a position where they cannot be removed by surgery
Researchers have found that some cancers have a change in a particular chemical process within the cancer cells. Scientists call the chemical process the hedgehog pathway (HH pathway). This chemical process is normally only active in the early stages of life and becomes less active as we become adults.
But researchers have found that most basal cell skin cancers have a change in the hedgehog pathway. This change switches on a signal to make the cells become cancerous and grow much more quickly than usual.
Vismodegib aims to block the signal within cells so that the cancer stops growing.
Researchers are also testing it for other types of cancer including cancer of the pancreas.
Vismodegib was licensed in the UK in August 2013. It hasn't yet been looked at by The National Institute for Health and Care (NICE). But it is on the cancer drugs fund list. So you can ask your doctors if it's suitable for you and if they agree, you can have it on the NHS.
There are some conditions for prescribing vismodegib through the cancer drugs fund. It must be prescribed by a cancer specialist and approved by the specialist team caring for people with skin cancers.
You must have basal cell cancer that has grown into body tissues around where it started or into nearby lymph glands - this is called locally advanced cancer. Or it must have spread elsewhere in your body - doctors call this metastatic or stage 4 cancer.
It must also not be possible for you to have surgery to cure your cancer. And you must have already had radiotherapy unless this is not possible in your case. You also have to be fit enough for the treatment.
Vismodegib is a tablet you take every day. You can take it with or without food. And you keep taking it until it stops working or the side effects become too great.
All new drugs go through a detailed research process. Firstly, research in the laboratory finds out if a potential new drug harms cancer cells in any way. Then researchers look at whether it is safe to give to people, what the dose should be, and which side effects it causes.
A phase 2 trial tested vismodegib in people who had basal cell skin cancer. The people who took part in the study had basal cell cancers that could not be removed with surgery or couldn’t have radiotherapy for one of the following reasons
- The cancer had spread to another part of the body (secondary cancer)
- The cancer had come back in the same area
- The cancer was too large (locally advanced) to remove
- The position meant that surgery or radiotherapy was not possible
The researchers found that the cancers shrank in about 3 out of 10 people (30%) whose cancer had spread to another part of the body. They shrank in 4 out of 10 people (40%) whose cancer had spread into nearby tissue (locally advanced disease).
In about 2 in 10 people (20%) with locally advanced disease there were no cancer cells when the researchers took a sample of tissue (biopsy) of where the cancer had been.
The average amount of time before the cancer started growing again was about 7½ months. For some people it was less than this and for others longer.
A number of other trials are looking at how well vismodegib works and finding out more about the side effects.
Researchers are still finding out about the side effects of vismodegib. In the research so far, more than 10 in every 100 people had one or more of these effects
- Muscle spasms
- Hair loss
- Taste changes
- Weight loss
- Feeling and being sick
- Loss of appetite
- Aching muscles and joints
- Women stopped having periods (amenorrhoea)
The links above take you to information about dealing with the side effects.
Vismodegib can have a harmful effect on a developing baby and it is not advisable to become pregnant or father a child if you are having this treatment. If you are having the treatment as part of a clinical trial it is important to talk about contraception with your doctor or nurse before treatment starts. If there is a possibility you could be pregnant your doctor may ask you to have a pregnancy test before you start treatment.
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