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Merck KGaA, Pfizer get FDA breakthrough status for kidney cancer therapy

The U.S. Food and Drug Administration has granted breakthrough therapy status to Merck KGaA and Pfizer Inc.'s Bavencio, or avelumab, in combination with Inlyta to treat advanced kidney cancer.

Merck and Pfizer formed a strategic alliance to co-develop and co-commercialize avelumab in November 2014.

The agency's decision is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a phase 1b study assessing the safety and efficacy of avelumab in combination with Inlyta for treatment-naïve patients with advanced renal cell carcinoma.

Bavencio is approved by the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma and patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.