Chinese firm, Junshi Biosciences announced that the US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma. Toripalimab is the first anti-PD-1 antibody from China to receive the Breakthrough Therapy designation. US FDA had granted orphan drug designation for this indication in May 2020.

“The Breakthrough Therapy designation granted by FDA recognises the significant clinical benefits Toripalimab has shown for the treatment of nasopharyngeal carcinoma. The BTD will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously,” commented Dr Ning Li, CEO of Junshi Biosciences.

The Breakthrough Therapy designation is derived from the provisions of the US Food and Drug Administration Safety and Innovation Act (FDASIA) and aims to expedite the development and review process of drugs intended to treat a serious condition when preliminary clinical evidence indicates that the drug may result in substantial improvement over available therapies on a clinically significant endpoint. BTD is another important new drug review channel for the FDA following the fast track, accelerated approval, and priority review.

According to regulations, the drug development process that has obtained breakthrough drug therapy certification will receive closer guidance and various forms of support, including from senior FDA officials, to ensure that patients are provided with new treatment options in the shortest time.

The FDA Breakthrough Therapy designation for Toripalimab for the treatment of nasopharyngeal carcinoma can significantly support and accelerate the commercial development plan of Toripalimab in the US.