Af­ter years of de­lay, BeiGene fi­nal­ly lands FDA ap­proval for its PD-1 drug

BeiGene has won the first FDA ap­proval for its PD-1 in­hibitor, mark­ing a hard-earned mile­stone af­ter a wind­ing reg­u­la­to­ry jour­ney that be­gan two and a half years ago.

Tevim­bra, the brand name for the an­ti­body al­so known as tislelizum­ab, will be avail­able in the US in the sec­ond half of 2024, BeiGene said in a press re­lease. It is cleared to treat metasta­t­ic esophageal squa­mous cell car­ci­no­ma (ES­CC) af­ter pri­or chemother­a­py.

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