17 April 2014 - 17 April 2014 - Japanese Chugai Pharmaceutical Co Ltd (TYO:4519), part of Swiss Roche (VTX:ROG), said Thursday it would introduce in Japan the anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla (trastuzumab emtansine) Intravenous Infusion 100 mg and 160 mg as a therapy of HER2-positive inoperable or recurrent breast cancer on April 18, 2014.

In Japan, Kadcyla was authorised for manufacture and marketing on September 20, 2013 and was included on the National Health Insurance (NHI) reimbursement price list on April 17, 2014.

After the product licence, Chugai commenced a clinical trial of Kadcyla at a small number of medical institutions in January 2014 to provide access to patients. The trial aimed to deliver Japanese clinical results for the therapy. As patient recruitment has reached the target number and access will be normalised after the drug introduction, the company will discontinue the trial and will compile the findings.

Kadcyla is an antibody drug conjugate that contains the anti-HER2 humanised monoclonal antibody, trastuzumab, and a cytotoxic tubulin polymerization inhibitor, DM1, attached together using a stable linker. Kadcyla is intended to target HER2, thus inhibiting HER2 signaling and inducing antibody-dependent cell mediated cytotoxicity, while simultaneously the tubulin polymerization inhibitor DM1 is directly delivered inside the HER2-positive cancer cells to kill them.

Kadcyla was cleared as a therapy of patients with previously treated, HER2-positive metastatic breast cancer in the USA in February 2013 and in Europe in November 2013.