On 28 February 2017, the Food and Drug Administration (FDA) approved the oral tryptophan hydroxylase (TPH) inhibitor, telotristat ethyl (Xermelo™, Lexicon Pharmaceuticals), at a dose of 250 mg in combination with a somatostatin analogue (SSA) for the treatment of metastatic neuroendocrine tumors (NETs)–associated carcinoid syndrome diarrhea that is inadequately controlled by SSA therapy alone.
In the open-label, phase III, TOWER trial, the CD3/CD19 bi-specific T-cell engaging (BiTE) antibody blinatumomab significantly improved overall survival (OS) and reduced risk of death by 29% compared to standard chemotherapy in patients with relapsed or refractory Philadelphia chromosome (Ph)-negative B cell precursor acute lymphoblastic leukemia (ALL).
On 14 March 2017, the programmed death receptor 1 (PD-1) inhibitor pembrolizumab (Keytruda®, Merck) received accelerated approval from the United States Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma who are refractory or have relapsed after three or more lines of therapy.
According to results from the open-label randomized phase III Keynote-045 study, the programmed death receptor 1 (PD-1) inhibitor pembrolizumab significantly improved overall survival (OS) compared to chemotherapy in patients with progressive advanced urothelial cancer regardless of PD-L1 expression status.
On 13 March 2017, the United States Food and Drug Administration (FDA) approved the second selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor ribociclib (Kisqali®, Novartis) for use in combination with an aromatase inhibitor as initial treatment for postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer.