From clinical trials to the patient
In the U.S., the Food and Drug Administration
(FDA) is responsible for approving new drugs
and approving the expanded use of drugs that
are already on the market. Drugs that are tested
in clinical trials and show promise are reviewed
by the FDA. The FDA considers the drug’s safety,
effectiveness, risks and benefits. If the drug is
judged to be safe and effective, and its benefits
outweigh its risks, the FDA may approve the
drug for use in people.
Some drugs that have not been given full approval
for distribution to the public can still be approved
for use within a specific clinical trial. This type
of approval allows promising drugs to be tested
further so their safety and effectiveness can continue
to be evaluated.
Remember that just because a drug is new, does
not mean that it is better than one that is currently
available. It’s just different. For example, one drug
may be most effective for persons with estrogen
receptor positive breast cancer. Another drug may
be used only after breast cancer has spread to other
parts of the body. Each person must work with her
own doctor to find the therapy that will work best
for her body and her disease.
A review of some approved drugs for the treatment
of breast cancer is presented below.
This list does not contain all of the drugs approved
for the treatment of breast cancer.
Herceptin
Type of drug: monoclonal antibody
A class of drugs developed to work alone or together
with chemotherapy to seek out and attack specific
cancer cells.
How it works: Herceptin attaches itself to a protein
called HER2 that is found on the surface of 20 to 25
percent of breast cancers. HER2 stimulates cell growth
and prevents breast cancer cell death. When Herceptin
binds to HER2 it can prevent the tumor from growing.
When prescribed: 1) for HER2 positive metastatic
breast cancer in cases where chemotherapy treatment
has been used and is no longer effective; 2) for
metastatic breast cancer, used in combination with
various chemotherapy drugs; 3) for treatment of early
breast cancer that is HER2 positive.
Taxotere and Taxol
Type of drug: chemotherapy agent
A class of drugs used to slow the growth of cancer or
to kill cancer cells that have spread to other parts of
the body.
How it works: Taxotere prevents cancer cells from
dividing. If cancer cells can’t divide, they can’t grow.
When prescribed: for people with metastatic breast
cancer or those with node positive early breast cancer.
Raloxifene
Type of drug: Selective Estrogen Receptor Modulators
(SERMs)
How it works: Some breast cancers need estrogen to
grow. Estrogen attaches to the breast cancer cells and
promotes growth. When raloxifene is used, it blocks
estrogen’s ability to promote tumor growth.
When prescribed: 1) for postmenopausal women in
preventing and treating osteoporosis; 2) some groups
of women, also lowers the risk of developing breast
cancer.
Xeloda
Type of drug: chemotherapy agent
A class of drugs used to slow the growth of cancer or
to kill cancer cells that have spread to other parts of
the body.
How it works: This drug is changed by breast cancer
cells into a chemotherapy drug called 5-fluorouacil.
For some people, this substance kills cancer cells
and shrinks the size of the tumor.
When prescribed: 1) for people with advanced breast
cancer whose tumors grew after treatment with Taxol
or Taxotere and an anthracycline (Adriamycin or
doxorubicin) chemotherapy; 2) for people with
advanced breast cancer whose tumors are resistant
to Taxol and when additional use of an anthracycline
(Adriamycin or doxorubicin) is not recommended;
3) for people with metastatic breast cancer, in
combination with Taxotere chemotherapy.
Femara, Arimidex, Aromasin
Type of drug: aromatase inhibitor
A class of drugs used to treat breast cancer in
postmenopausal women that may be stimulated
to grow by estrogen.
How it works: These drugs block estrogen production
in postmenopausal women. This limits the amount of
estrogen that can affect cancer cells.
When prescribed: 1) for postmenopausal women
with advanced breast cancer with positive or unknown
hormone receptors; 2) for women who did not
respond well or whose breast cancer became resistant
to tamoxifen; 3) for postmenopausal women without
metastasis.
FDA approval for drugs and their use is a process. This
active area of research may lead to changes in their
use. Talk to your doctor about what is right for you.
In the U.S., the Food and Drug Administration
(FDA) is responsible for approving new drugs
and approving the expanded use of drugs that
are already on the market. Drugs that are tested
in clinical trials and show promise are reviewed
by the FDA. The FDA considers the drug’s safety,
effectiveness, risks and benefits. If the drug is
judged to be safe and effective, and its benefits
outweigh its risks, the FDA may approve the
drug for use in people.
Some drugs that have not been given full approval
for distribution to the public can still be approved
for use within a specific clinical trial. This type
of approval allows promising drugs to be tested
further so their safety and effectiveness can continue
to be evaluated.
Remember that just because a drug is new, does
not mean that it is better than one that is currently
available. It’s just different. For example, one drug
may be most effective for persons with estrogen
receptor positive breast cancer. Another drug may
be used only after breast cancer has spread to other
parts of the body. Each person must work with her
own doctor to find the therapy that will work best
for her body and her disease.
A review of some approved drugs for the treatment
of breast cancer is presented below.
This list does not contain all of the drugs approved
for the treatment of breast cancer.
Herceptin
Type of drug: monoclonal antibody
A class of drugs developed to work alone or together
with chemotherapy to seek out and attack specific
cancer cells.
How it works: Herceptin attaches itself to a protein
called HER2 that is found on the surface of 20 to 25
percent of breast cancers. HER2 stimulates cell growth
and prevents breast cancer cell death. When Herceptin
binds to HER2 it can prevent the tumor from growing.
When prescribed: 1) for HER2 positive metastatic
breast cancer in cases where chemotherapy treatment
has been used and is no longer effective; 2) for
metastatic breast cancer, used in combination with
various chemotherapy drugs; 3) for treatment of early
breast cancer that is HER2 positive.
Taxotere and Taxol
Type of drug: chemotherapy agent
A class of drugs used to slow the growth of cancer or
to kill cancer cells that have spread to other parts of
the body.
How it works: Taxotere prevents cancer cells from
dividing. If cancer cells can’t divide, they can’t grow.
When prescribed: for people with metastatic breast
cancer or those with node positive early breast cancer.
Raloxifene
Type of drug: Selective Estrogen Receptor Modulators
(SERMs)
How it works: Some breast cancers need estrogen to
grow. Estrogen attaches to the breast cancer cells and
promotes growth. When raloxifene is used, it blocks
estrogen’s ability to promote tumor growth.
When prescribed: 1) for postmenopausal women in
preventing and treating osteoporosis; 2) some groups
of women, also lowers the risk of developing breast
cancer.
Xeloda
Type of drug: chemotherapy agent
A class of drugs used to slow the growth of cancer or
to kill cancer cells that have spread to other parts of
the body.
How it works: This drug is changed by breast cancer
cells into a chemotherapy drug called 5-fluorouacil.
For some people, this substance kills cancer cells
and shrinks the size of the tumor.
When prescribed: 1) for people with advanced breast
cancer whose tumors grew after treatment with Taxol
or Taxotere and an anthracycline (Adriamycin or
doxorubicin) chemotherapy; 2) for people with
advanced breast cancer whose tumors are resistant
to Taxol and when additional use of an anthracycline
(Adriamycin or doxorubicin) is not recommended;
3) for people with metastatic breast cancer, in
combination with Taxotere chemotherapy.
Femara, Arimidex, Aromasin
Type of drug: aromatase inhibitor
A class of drugs used to treat breast cancer in
postmenopausal women that may be stimulated
to grow by estrogen.
How it works: These drugs block estrogen production
in postmenopausal women. This limits the amount of
estrogen that can affect cancer cells.
When prescribed: 1) for postmenopausal women
with advanced breast cancer with positive or unknown
hormone receptors; 2) for women who did not
respond well or whose breast cancer became resistant
to tamoxifen; 3) for postmenopausal women without
metastasis.
FDA approval for drugs and their use is a process. This
active area of research may lead to changes in their
use. Talk to your doctor about what is right for you.
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