FDA con­verts No­var­tis' NSCLC drug to a full ap­proval with con­fir­ma­to­ry da­ta

Al­though No­var­tis dis­con­tin­ued its re­search in­to the use of Tabrec­ta in sol­id tu­mors, the FDA on Thurs­day an­nounced that its ac­cel­er­at­ed ap­proval would be con­vert­ed in­to a full ap­proval for adults with metasta­t­ic non-small cell lung can­cer (NSCLC) whose tu­mors have a mu­ta­tion lead­ing to mes­enchy­mal-ep­ithe­lial tran­si­tion (MET) ex­on 14 skip­ping.

The twice-dai­ly pill, which pulled in $90 mil­lion to start in 2021, has seen its US launch progress well, the Big Phar­ma said in its lat­est an­nu­al re­port.

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