Genentech, a member of the Roche Group, today
announced that the U.S. Food and Drug Administration (FDA) has approved
Kadcyla™ ^ (ado-trastuzumab emtansine or T-DM1) for the treatment of people
with HER2-positive metastatic breast cancer (mBC) who have received prior
treatment with Herceptin^® (trastuzumab) and a taxane chemotherapy. Kadcyla is
the fourth medicine from Genentech to receive FDA approval for people with
advanced cancers within the past two years.
An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine
that can attach to certain types of cancer cells and deliver chemotherapy
directly to them. Kadcyla is the first FDA-approved ADC for treating
HER2-positive mBC, an aggressive form of the disease.
“Kadcyla is an antibody-drug conjugate representing a completely new way to
treat HER2-positive metastatic breast cancer, and it helped people in the
EMILIA study live nearly six months longer,” said Hal Barron, M.D., chief
medical officer and head, Global Product Development. “We currently have more
than 25 antibody-drug conjugates in our pipeline and hope this promising
approach will help us deliver more medicines to fight other cancers in the
future.”
Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1,
joined together using a stable linker. Kadcyla combines the mechanisms of
action of both trastuzumab and DM1, and it is the first Genentech ADC approved
by the FDA. Genentech has studied ADC science for more than a decade and has
eight ADCs in Phase I or Phase II studies for different types of cancer.
Kadcyla will be available to people in the United States within two weeks. As
part of this approval, Genentech plans to initiate patient assistance programs
for people taking Kadcyla through Genentech Access Solutions. These programs
help people who might not be able to afford this medicine. People who do not
have health insurance, or who have reached the lifetime limit set by their
insurance company, might qualify to receive Kadcyla free of charge. For people
with insurance, Genentech Access Solutions offers co-pay assistance programs
to help with the out-of-pocket costs of their medicine, including a co-pay
card for those with private insurance. The card pays 80 percent of
out-of-pocket costs for people who qualify (up to $9,000 or $24,000 per year,
depending on the person's income).
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