lapatinib — Medica
Breast cancer
Initial criteria
- age ≥ 18 years
- human epidermal growth factor receptor 2 (HER2)-positive disease
- recurrent or metastatic disease
- EITHER:
- Used in combination with capecitabine or trastuzumab AND patient has tried at least three prior anti-HER2 based regimens (examples include pertuzumab + trastuzumab + docetaxel, pertuzumab + trastuzumab + paclitaxel, fam-trastuzumab deruxtecan-nxki, ado-trastuzumab emtansine, tucatinib + trastuzumab + capecitabine)
- OR used in combination with an aromatase inhibitor (letrozole, anastrozole, or exemestane) AND hormone receptor-positive (ER+ and/or PR+) AND ONE of the following: postmenopausal woman OR pre/perimenopausal woman receiving ovarian suppression/ablation with a GnRH agonist/surgical oophorectomy/ovarian irradiation OR man receiving a GnRH analog
Approval duration
1 year