Lapatinib ditosylate

PBAC's latest decision on Lapatinib ditosylate: Not recommended (2007). Considered for Initial treatment of patients with HER2-positive metastatic breast cancer who have received prior therapy with an anthracycline and a taxane administered either concurrently or separately, except where the patient is intolerant or contra-indicated to those agents, and whose disease progresses despite treatment with trastuzumab or who meet the trastuzumab-exemption criteria.

Eligible population

patients with HER2-positive metastatic breast cancer who have received prior therapy with an anthracycline and a taxane, and whose disease progresses despite treatment with trastuzumab or who meet the trastuzumab-exemption criteria

Therapy area

Oncology

Line of therapy

Later-line

Evidence base

RCT | Single-arm | Registry

Primary endpoint

OS | PFS

Key trials

EGF100151, EGF100151/EGF100151, Bartsch et al, Furukawa et al, Montemurro et al, Garcia-Saenz et al, Stemmler, HJ et al, Tripathy D et al, Gelmon et al, Fountzilas et al

Comparator

mixed comparator of five different agents weighted by usage: capecitabine monotherapy, trastuzumab monotherapy, trastuzumab + vinorelbine, trastuzumab + capecitabine, trastuzumab + taxane, gemicitabine + taxane

Economic model

CUA

ICER note

ICER varies widely depending on assumed extent of substitution of lapatinib for continued trastuzumab treatment; example provided for 50% trastuzumab continuation assumption

Why PBAC said no