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Roche drug for late-stage breast cancer approved

Washington, February 23, 2013

 

US health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.
 
The US Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.
 
The drug's label will carry a boxed warning, the most serious possible, of the Kadcyla's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.
 
Still, fewer patients in a clinical trial experienced severe side effects than those who received standard therapy.
 
The approval was based on a study of about 1,000 women who had already been treated with Roche's drug Herceptin and a taxane chemotherapy. Patients who were given Kadcyla survived an average of 30.9 months, compared with 25.1 months for those in the control arm who took Xeloda and GlaxoSmithKline Plc's Tykerb.
 
The drug will be priced at $9,800 a month, higher than Wall Street analysts had expected but likely acceptable to insurers.
 
"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeonidis, an analyst at Cowen and Company, in a research note on Friday.
 
Kadcyla works by attaching Herceptin, also known as trastuzumab, to a drug called DM1, developed by ImmunoGen Inc , which interferes with cancer cell growth.
 
"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 FDA's office of hematology and oncology products.
 
Other drugs approved for HER2-positive breast cancer include Herceptin, Tykerb, and Perjeta, or pertuzumab, which is also made by Roche and was approved in 2012.
 
Kadcyla is a member of a class of drugs known as antibody-drug conjugates, or "armed antibodies." They combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case DM1, and a link that binds them together to deliver a highly potent bomb within the diseased cells.
 
The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.
 
The first conjugate to be approved was Mylotarg which was pulled from the market in 2010 by Pfizer Inc's after a study showed it did not extend survival for patients with myeloid leukemia, a bone marrow cancer.
 
In 2011, Seattle Genetics won US approval for Adcentris, a conjugate targeting Hodgkin's lymphoma, several types of T-cell lymphoma and other hematologic malignancies.
 
Kadcyla is the first armed antibody to be approved to treat a solid tumor. -Reuters



Tags: FDA | Breast cancer | Roche |

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