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EMA validates Bavencio for review in advanced RCC
The European Medicines Agency (EMA) has validated Merck’s application for Bavencio (avelumab) for the treatment of patients with advanced renal cell carcinoma (RCC).
The review is for the Type II variation application of the drug in combination with Inlyta (axitinib), and is based on results from the pivotal Phase III JAVELIN Renal 101 trial.
JAVELIN involves at least 30 clinical programs and more than 9,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include breast, gastric/gastro-esophageal junction, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma.
The trial results were published in the New England Journal of Medicine on February 16, 2019.
The US Food and Drug Administration (FDA) has also accepted a supplemental Biologics License Application for the drug combination, for patients with advanced RCC for Priority Review.
The target date is June 2019, and a supplemental application for the combination in unresectable or metastatic RCC has also been submitted in Japan.
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