Roche has announced that Kadcyla ( Trastuzumab emtansine or T-DM1 ) has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.
Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin ( Trastuzumab ) and a taxane, separately or in combination.
The indication also stipulates that those treated should either have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during or within six months of completing adjuvant therapy.
The decision is based on results from the pivotal Phase III EMILIA study in which people previously treated with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomised to receive either Kadcyla or a standard treatment, Lapatinib ( Tyverb, Tykerb ) and Capecitabine ( Xeloda ).
People receiving Trastuzumab emtansine survived significantly longer than those who received Lapatanib and Capecitabine ( 30.9 vs 25.1 months ) and also lived for nearly 10 months ( 9.6 months ) without their disease getting worse, a median of 3.2 months longer than those who received Lapatinib and Capecitabine. They also experienced fewer of the severe side effects commonly associated with chemotherapy, as Trastuzumab emtansines targeted mode of action works to deliver the treatment directly to cancer cells, limiting damage to healthy tissues.
Kadcyla is the third targeted medicine Roche has developed for the treatment of HER2-positive breast cancer. It is an antibody-drug conjugate and it connects two anti-cancer properties: the HER2 inhibition of Trastuzumab and the cytotoxic chemotherapy, DM1. The Trastuzumab and the DM1 are joined together using a stable linker to deliver DM1 directly to HER2-positive breast cancer cells. ( Xagena )
Source: Roche, 2013