FDA
cho phép dùng thuốc mới Tykerb điều trị Ung Thư Vú Nặng, Di Căn
Tykerb là một phân tử mới đóng chức năng như một chất kìm
hãm kinase.
Tykerb chui vào tế bào, khử chức năng tế bào ung thư và một số bạch đản
khác.
Tykerb có tác dụng khả quan khi tế bào ung thư vú chứa bạch đản dương
tính HER2.
FDA Approves Tykerb for Advanced Breast
Cancer Patients
The Food and Drug Administration (FDA) today approved Tykerb (lapatinib),
a new targeted anti-cancer treatment, to be used in combination with capectabine
(Xeloda), another cancer drug, for patients with advanced, metastatic
breast cancer that is HER2 positive (tumors that exhibit HER2 protein).
The combination treatment is indicated for women who have received prior
therapy with other cancer drugs, including an anthracycline, a taxane,
and trastuzumab (Herceptin). According to the American Cancer Society,
about 180,000 new cases of breast cancer are diagnosed each year. Approximately
8,000 to 10,000 women die from metastatic HER2 positive breast cancer
each year.
Tykerb, a new molecular entity (NME), is a kinase inhibitor working through
multiple pathways (targets) to deprive tumor cells of signals needed to
grow. Unlike, for example, trastuzumab — a monoclonal antibody, which
is a large protein molecule that targets the part of the HER2 protein
on the outside of the cell — Tykerb is a small molecule that enters the
cell and blocks the function of this and other proteins. Because of this
difference in mechanism of action, Tykerb works in some HER2 positive
breast cancers that have been treated with trastuzumab and are no longer
benefiting.
"Today's approval is a step forward in making new treatments available
for patients who have progression of their breast cancer after treatment
with some of the most effective breast cancer therapies available,"
said Steven Galson, MD, M.P.H., Director of FDA's Center for Drug Evaluation
and Research. "New targeted therapies such as Tykerb are helping
expand options for patients."
The approval of Tykerb was based on a randomized clinical trial in about
400 women with advanced or metastatic breast cancer that was also HER2
positive. In the trial, half the patients received Tykerb with capecitabine
and half received capecitabine alone. Compared to patients receiving capecitabine
alone, the group of patients receiving Tykerb with capecitabine had a
statistically significant improvement in the time to tumor progression.
In addition, the tumor response rate was higher in the group of patients
receiving Tykerb with capecitabine (24 percent vs. 14 percent). The survival
data are not yet mature.
The most commonly reported Tykerb-related side effects included diarrhea,
nausea, vomiting, rash and hand-foot syndrome which may include numbness,
tingling, redness, swelling and discomfort of hands and feet. Generally
reversible decreases in heart function (that can lead to shortness of
breath) have also been reported in a small percentage of patients. Patients
should talk to their doctor about potential side effects, potential drug
interactions, and other medical conditions including heart and liver problems.
Tykerb is available in tablets of 250 mg. An undivided dose of 1,250 mg
should be taken orally once daily for 21 days and in combination with
capecitabine on days 1-14 of a 21 day cycle.
Tykerb will be distributed by GlaxoSmithKline, of Research Triangle Park,
North Carolina.
