FDA 'Breakthrough' status for avelumab combination with Inlyta

The US Food and Drug Administration has granted Breakthrough Therapy designation for avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC), which is being developed by Germany’s Merck KGaA (MRK: DE) and US pharma giant Pfizer (NYSE: PFE).

Breakthrough Therapy designation is designed to accelerate the development and review of potential medicines for serious conditions, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over currently available therapies on one or more clinically significant endpoints. This is the second such designation granted to avelumab.

“A combination approach with an immunotherapy, whose activity may complement existing agents such as Inlyta, has the potential to improve outcomes for patients with advanced renal cancer – a disease where the five-year survival rate remains low,” said Chris Boshoff, senior vice president and head of immuno-oncology, early development and translational oncology, Pfizer Global Product Development. “Pfizer’s 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 we’re expecting at the end of next year,” Dr Boshoff noted.