Tags: breast | cancer | drug | europe | japan

Breast Cancer Drug Gets Approval for Use in Europe, Japan

Friday, 20 Sep 2013 05:21 PM

By Robin Farmer


Roche’s new breast cancer drug designed for patients with late-stage disease won approval for use in Japan and Europe on Friday.

Reuters reported that the backing in Japan and Europe of Kadcyla, also known as T-DMI, follows U.S. approval of the drug earlier this year.

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Designed for patients whose cancer cells contain increased amounts of a protein known as HER2, Kadcyla slows cancer cell growth and preserves quality of life, according to a Roche media release.

There is currently no cure for metastatic breast cancer.

“Kadcyla’s highly effective, targeted mode of action offers patients a chance to extend their lives with fewer of the side effects commonly experienced with chemotherapy,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development, in the media release. “We hope that this new medicine is soon available to patients with metastatic breast cancer in Europe.”

Patients in a clinical study who were treated with Kadcyla had their life expectancy extended to more than 18 months overall, according to the company.

The drug is pricey. According to BioWorld, a monthly course of Kadcyla costs $9,800.

Roche licenses technology for Kadcyla under an agreement with ImmunoGen Inc. Reuters reported that ImmunoGen gets a $5 million milestone payment from Roche following the Japanese approval.

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