A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’

With 163 additional cases of unexpected ADRs whose causal relationship cannot be ruled out also being reported in the same period, Kadcyla’s label will be changed.

The Ministry of Food and Drug Safety announced it will change the label for Kadcyla inj. 100mg and 160mg according to the reevaluation results as of December 28th.

Kadcyla received domestic marketing authorization in January 2014 to treat patients with