Print“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer.”
The U.S. Food and Drug Administration approved a new treatment for metastatic breast cancer, triggering a $10.5 million milestone payment to ImmunoGen from Roche and paving the way for ImmunoGen to receive royalty payments based on commercial sales of the drug.
The new therapy, developed under the name T-DM1, will be marketed as Kadcyla and offer a new option for women with HER2-positive breast cancers, a particularly aggressive form of the disease.
“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer,” says Hal Barron, chief medical officer and head of global product development at Roche-owned Genentech. “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, reviewed under the FDA’s priority review program, is an antibody-drug conjugate that pairs Herceptin with a powerful chemotherapy agent. The combination delivers the therapy directly to the tumor cells, bypassing healthy cells. It is the fourth drug to target HER2 approved by the FDA.
The therapy works by delivering the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival, says Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products.
In a clinical study of 991 patients randomly assigned to receive Kadcyla or another chemotherapy drug, patients treated with Kadcyla had a median progression-free survival of 9.6 months compared to 6.4 months in patients treated with the other drug, lapatinib plus capecitabine. The median overall survival was 30.9 months in the Kadcyla group and 25.1 months in the lapatinib plus capecitabine group.
Roche is still awaiting the result of a regulatory review of Kadyla’s marketing authorization application, filed with the European Medicines Agency. Meanwhile the company says that Kadcyla will be available for sale in the United States within two weeks.
March 01, 2013
http://www.burrillreport.com/article-fda_approves_new_breast_cancer_therapy.html
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