EMA accepts the application for authorization of Bavencio for renal cell carcinoma

The European Medicines Agency (EMA) accepted for consideration a authorization application from Merck KGaA for Bavencio (avelumab) for the treatment of patients with advanced renal cell carcinoma (CRP).

The regulator is considering the application for the use of Bavencio in combination with Inlyta (axitinib), which was submitted on the results of Phase III pivotal clinical trial (CI) JAVELIN Renal 101.

JAVELIN includes more than 30 research programs; more than 9 thousand patients with more than 15 different types of tumors take part in researches.

In addition to RCC, Bavencio therapy for breast cancer, gastric cancer / gastroesophageal cancer, head and neck cancer, Merkel carcinoma, non-small cell lung cancer and urothelial carcinoma is being investigated.

The CI results were published in the New England Journal of Medicine in February 2019.

The FDA also accepted an application for this combination of drugs for distributed RCC for an accelerated review.

CRP is the most common form of kidney cancer, which occurs in 2–3% of adults with this disease.

Link: pharmvestnik.ru