BREAST CANCER: Several new anti-HER2 agents on the horizon
BREAST CANCER Several new anti-HER2 agents on the horizon
1. FDA approval sought for tucatinib for patients with advanced disease, ASCOPost
U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1). The results of the HER2CLIMB clinical trial on which this designation is based were announced in October 2019, and additional data were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS)1 and simultaneously published in The New England Journal of Medicine.2 Tucatinib is an oral, small-molecule tyrosine kinase inhibitor that is highly selective for HER2
2. Neratinib showing efficacy for patients with brain metastasis
3. FDA granting accelerated approval for trastuzumab deruxtecan in advanced disease. ASCOPost
On December 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting. DESTINY-Breast01 and Study DS8201-A-J101 Efficacy was investigated in DESTINY-Breast01, a multicenter, single-arm trial enrolling 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies. Patients received 5.4 mg/kg of fam-trastuzumab deruxtecan-nxki by intravenous infusion every 3 weeks until unacceptable toxicity or disease progression.