Tivozanib, ribociclib EMA authorizations extend oncology armamentarium
medwireNews: The EMA has granted marketing authorizations for use of tivozanib in patients with advanced renal cell carcinoma (RCC) and for use of ribociclib in patients with locally advanced or metastatic breast cancer.
The vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, tivozanib hydrochloride monohydrate, was shown to extend progression-free survival in patients with treatment-naïve advanced RCC and may also be used for patients who are naïve to VEGFR and mTOR pathway inhibitor therapy but have progressed after one previous cytokine therapy.
Ribociclib, a selective tyrosine kinase inhibitor of cyclin-dependent kinase 4 and 6, was approved for use alongside an aromatase inhibitor as a primary treatment for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative disease that is locally advanced or metastatic.
The authorization follows research showing that ribociclib plus letrozole significantly improved progression-free survival in this patient population.
The EMA has also added a new hepatocellular indication for the oral multikinase inhibitor regorafenib, allowing treatment for adults who have previously received sorafenib therapy.
This follows earlier authorization for patients with prior treated metastatic colorectal cancer and inoperable or metastatic gastrointestinal stromal tumors after previous treatment with imatinib and sunitinib.
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