Genen­tech, Blue­print tout full ap­proval for Gavre­to in rare type of lung can­cer

Genen­tech and Blue­print Med­i­cines scored a full FDA ap­proval on Wednes­day for Gavre­to’s use in a small sub­set of non-small cell lung can­cer pa­tients, near­ly three years af­ter cel­e­brat­ing an ini­tial win via the ac­cel­er­at­ed ap­proval path­way.

Gavre­to, al­so known as pralse­tinib, was ap­proved in Sep­tem­ber 2020 for adults with metasta­t­ic NSCLC with RET fu­sions, which are present in just 1% to 2% of pa­tients, the Roche sub­sidiary said at the time. Reg­u­la­tors con­vert­ed the la­bel to a full ap­proval af­ter re­view­ing sup­port­ing da­ta from 123 ad­di­tion­al pa­tients over 25 more months of fol­low-up.

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