Roche’s breast cancer drug Kadcyla debuts in UK

Swiss drug major Roche’s (ROG: SIX) Kadcyla (ado-trastuzumab emtansine or T-DM1) is now available for UK patients with advanced HER2-positive breast cancer, its third European launch, the company announced this morning.

Kadcyla is the first medicine of its kind in breast cancer, consisting of the HER2-targeted antibody, trastuzumab (the active ingredient of Roche’s Herceptin), linked with the chemotherapy agent, DM1. In response to the pivotal Phase III EMILIA clinical trial, the European Medicines Agency has now granted a license for adult patients with advanced HER2-positive breast cancer who have previously received Herceptin and a taxane, separately or in combination (The Pharma Letter November 20, 2013).

In Europe, the drug has already been launched in Germany and Switzerland, and it is also on the market in the USA. Kadcyla is expected to take the heat of biosimilar challenges to its blockbuster drug Herceptin, which could surface in 2016. Patents for Herceptin are due to expire in 2014 in Europe and Japan, and in 2015 in the USA. Analysts estimate that Kadcyla could generate annual peak sales of $2 billion to $5 billion. Herceptin, however, generated sales of 6.08 billion Swiss francs ($6.77 billion) for 2013.