Nov 14: FDA approves Chinese lymphoma treatment

The United States Food and Drug Administration announced on Nov 15 Beijing time its accelerated approval of the drug for treatment of adult patients with mantle cell lymphoma.

The FDA's approval for Chinese biomedicine company BeiGene Ltd's Brukinsa (zanubrutinib) capsules marked a breakthrough for Chinese drug developers. It is the first time an innovative therapy from a Chinese mainland drug developer will enter the US market, while the majority of new drugs, especially cancer therapies, from the Chinese market are imported, industry insiders said.

The accelerated approval is based on overall response rate, or how many patients experience a complete or partial shrinkage of their tumors after treatment.

Mantle cell lymphoma, or MCL, is a rare, aggressive form of non-Hodgkin's lymphoma, which is a cancer developing from lymphocytes, a type of white blood cell. It usually responds well to initial treatment but eventually returns or stops responding, and cancer cells continue to grow.