(CNN) -- A drug that presents a new way to knock out
cancer cells was approved Friday to treat patients with a certain type
of late-stage metastatic breast cancer.
The drug, referred to as T-DM1 during clinical research, will now be known by the brand name Kadcyla, the Food and Drug Administration said in its approval announcement. It's a new therapy for women with HER2-positive breast cancer.
Kadcyla is a combination
of the targeted drug trastuzumab -- better known by the brand name
Herceptin -- and a powerful chemotherapy drug called emtansine, or DM1.
It's designed to work when Herceptin alone can no longer keep cancer in
check.
DM1 is too toxic to
deliver directly into a patient's bloodstream, like other chemotherapy
drugs. The Herceptin part of the new drug homes in on cancer cells,
sparing other healthy cells, and delivers DM1 into the cell.
"Kadcyla delivers the
drug to the cancer site to shrink the tumor, slow disease progression
and prolong survival," said Dr. Richard Pazdur, director of the Office
of Hematology and Oncology Products in the FDA's Center for Drug
Evaluation and Research, in a statement. The drug is the fourth approved
to target the HER2 protein.
Genentech,
the company that developed the drug, is working to get it to patients
"imminently," said spokesman Susan Willson. "As soon as humanly
possible, but within two weeks at the outside."
Kadcyla will cost about
$9,800 monthly, which Willson said is "similar to the cost of other
treatment regimens in this line of therapy." The estimated cost of a
course of Kadcyla -- 9½ months -- is about $94,000.
But "we want to ensure
that people who are eligible for this medicine have access to it,"
Willson said. Genentech plans to initiate patient assistance programs
for the drug to help those who might not be able to afford it; those
without health insurance or those who have reached the lifetime limit
set by their insurance companies may qualify to receive Kadcyla for
free.
Experimental drug offers new way to battle certain breast cancer
Breast cancer is the
second leading cause of cancer-related deaths among women, according to
the National Cancer Institute and the U.S. Centers for Disease Control and Prevention.
HER2 is a protein
involved in normal cell growth. It's found in increased amounts on some
types of cancer cells. In HER2-positive breast cancers, the increased
amount of the protein contributes to cancer call growth and survival.
Nearly 20% of breast cancers have increased amounts of HER2.
Researchers announced
the results of a large three-year clinical trial of Kadcyla in June,
saying they were optimistic about it. One significant benefit, according
to lead study author Dr. Kimberly Blackwell of Duke University, is the
lack of significant side effects and a better quality of life for
patients on the drug.
Patients participating
in the trial, she said, were the first group for whom officials worried
about fixing their hair for media interviews.
Kadcyla, known as an
"antibody-drug conjugate," represents "a completely new way" to treat
HER2 positive metastatic breast cancer, said Dr. Hal Barron, chief
medical officer and head of global product development for Genentech.
An antibody-drug
conjugate is described by the company as "a new kind of targeted
medicine that can attach to certain types of cells and deliver
chemotherapy directly to them."
"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," Barron said in a statement.
A new drug offers a new way to treat patients with a certain kind of late-stage breast cancer.
