Pfizer’s Inlyta Receives NMPA Approval for First-line Renal Cell Carcinoma Combination Therapy

Pfizer's Inlyta Receives NMPA Approval for First-line Renal Cell Carcinoma Combination Therapy

US giant Pfizer Inc. (NYSE: PFE) announced last week that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Inlyta (axitinib). The approval authorizes Inlyta for use in combination with toripalimab as a first-line treatment for moderate to high-risk unresectable or metastatic renal cell carcinoma (RCC). This marks the first and only first-line targeted combination immunotherapy for RCC available in China.

Basis for Approval
The approval was based on positive results from the pivotal Phase III RENOTORCH study conducted in patients with advanced RCC in China. This study provided the necessary evidence to support the efficacy and safety of the combination therapy.-Fineline Info & Tech