Caplacizumab-yhdp (Cablivi)
Class: Monoclonal antibody fragment directed against von Willebrand factor.
Disease: Thrombotic thrombocytopenic purpura.
Dose: 11 mg IV initially, then daily subcutaneously; in combination with plasma exchange and immunosuppressive therapy.
AEs: Epistaxis, headache, and gingival bleeding.
Trial: Hercules trial (NCT02553317): More rapid normalization of platelets, lower incidence of composite TTP-related death, and lower rate of recurrence when added to plasma exchange and steroids.
Alpelisib (Piqray)
Class: Phosphatidylinositol-3-kinase (PI3K) inhibitor.
Disease: Hormone receptor positive HER2-negative PIK3CA-mutated, advanced or metastatic breast cancer.
Dose: 300 mg orally once daily with food with concomitant fulvestrant.
AEs: Hyperglycemia, pancytopenia.
Trial: SOLAR-1 (NCT02437318): 11-month progression-free survival among patients treated with alpelisib and fulvestrant, compared with 5.7 months in fulvestrant alone control arm; overall response rate of 36% versus 16%, respectively.
Erdafitinib (Balversa)
Class: Fibroblast growth factor receptor kinase inhibitor.
Disease: Locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 mutations.
Dose: 8 mg orally once daily, with or without food.
AEs: Ocular disorders including retinopathy or retinal detachment.
Trial: BLC2001 (NCT02365597): Objective response rate of 32.2%, with a complete response in 2.3% of patients and partial response in 29.9% of patients.
Biosimilar approvals
Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)
Biosimilar to: Trastuzumab.
Indication: HER2-overexpressing breast cancer.
Dr. Bryer is a resident in the department of internal medicine at the University of Pennsylvania, Philadelphia. Dr. Mintzer is chief of hematology-oncology at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania. Dr. Henry is a hematologist-oncologist at Pennsylvania Hospital and professor of medicine at the University of Pennsylvania.
*Correction, 11/7/2019: An earlier version of this article misstated the drug combination in the GO29365 trial.