FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma
Summary
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE ) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA ® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC)."Pfizers expertise in developing treatments for advanced RCC is a distinct advantage in tackling this tumor type, and we look forward to the completion of our Phase III study combining avelumab with INLYTA, which were expecting at the end of next year."The Breakthrough Therapy Designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global Phase Ib study assessing the safety and efficacy of avelumab in combination with INLYTA for the treatment of treatment-naïve patients with advanced RCC.The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.