FDA ex­pands la­bel for No­var­tis and Roche's block­buster, con­verts EMD Serono's NSCLC drug to full ap­proval

The FDA on Fri­day signed off on an ex­pand­ed la­bel for No­var­tis and Roche’s block­buster Xo­lair (oma­l­izum­ab) and on Thurs­day con­vert­ed the ac­cel­er­at­ed to full ap­proval for EMD Serono’s non-small cell lung can­cer drug Tep­metko (tepo­tinib).

The ex­pand­ed ap­proval for Xo­lair is based on a pos­i­tive NIH-fund­ed Phase III study, af­ter an in­ter­im look at the da­ta by the study’s da­ta man­age­ment board found that study par­tic­i­pants who re­ceived oma­l­izum­ab could con­sume high­er dos­es of peanut, egg, milk and cashew with­out al­ler­gic re­ac­tions than par­tic­i­pants who re­ceived place­bo in­jec­tions.

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