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Merck KGaA and Pfizer Inc partnership awarded US FDA's breakthrough therapy designation for avelumab in combination with INLYTA in advanced renal cell carcinoma.

M2 EQUITYBITES-December 22, 2017-Merck KGaA and Pfizer Inc partnership awarded US FDA's breakthrough therapy designation for avelumab in combination with INLYTA in advanced renal cell carcinoma

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Healthcare company Merck KGaA and Pfizer Inc (NYSE:PFE) Thursday jointly announced the US Food and Drug Administration's (FDA) breakthrough therapy designation for avelumab in combination with INLYTA (axitinib) for treatment-naAaAaAeA ve patients with advanced renal cell carcinoma (RCC the most common form of kidney cancer.

The US FDA's breakthrough therapy designation is based on the preliminary evaluation of clinical data from the partnership's JAVELIN Renal 100, a global Phase Ib study assessing the safety and efficacy of avelumab in combination with INLYTA for the treatment of treatment-naAaAaAeA ve patien with advanced RCC.

JAVELIN Renal 100 is a Phase Ib, open-label, multicentre, multiple-dose study investigating avelumab in combination with INLYTA (axitinib), a tyrosine kinase inhibitor from Pfizer, for the treatment of treatment-naAaAaAeA patients with advanced RCC. The study enrolled 55 patients from participating sites in the US, UK and Japan.

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models, said the company.

INLYTA is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumour growth, vascular angiogenesis and progression of cancer (the spread of tumors), stated the company.

In conjunction, the updated results from the company's Phase Ib study were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

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Publication:M2 EquityBites (EQB)
Date:Dec 22, 2017
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