lapatinib (Tyverb)

ADVICE: following a re-submission

lapatinib (Tyverb®) is not recommended for use within NHS Scotland.

Indication under review: in combination with capecitabine, for the treatment of patients with
advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who
have progressive disease following prior therapy including anthracyclines and taxanes and
therapy with trastuzumab in the metastatic setting.

In a randomised open-label study the median time to progression for lapatinib plus
capecitabine was significantly longer than for capecitabine monotherapy. There was no
statistically significant difference in overall survival.

Compared with capecitabine monotherapy, the manufacturer’s justification of the treatment’s
cost in relation to its health benefits was not sufficient to gain acceptance by SMC. There
was also uncertainty about the comparative effectiveness and cost-effectiveness compared
to unlicensed use of trastuzumab and capecitabine in patients with metastatic disease
confined to the central nervous system, itself a treatment of unproven cost-effectiveness.