After yearlong delay, FDA completes inspection for Novartis, BeiGene’s anti-PD-1 drug from China

The FDA has com­plet­ed its man­u­fac­tur­ing in­spec­tion for tislelizum­ab and the ap­pli­ca­tion is mov­ing for­ward, No­var­tis’ part­ner BeiGene an­nounced Tues­day morn­ing at its R&D day pre­sen­ta­tion.

The FDA had de­layed its de­ci­sion on the drug in­def­i­nite­ly in sec­ond-line un­re­sectable or metasta­t­ic esophageal squa­mous cell car­ci­no­ma (ES­CC) last Ju­ly, and BeiGene and No­var­tis had dis­closed at the time that the reg­u­la­to­ry agency was un­able to com­plete its in­spec­tion due to Covid-re­lat­ed trav­el re­stric­tions. If tislelizum­ab wins ap­proval in the US, it would be­come the first check­point in­hibitor ini­tial­ly de­vel­oped in Chi­na to en­ter the US mar­ket. The drug is al­ready ap­proved for a num­ber of can­cers in Chi­na.

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