NATALEE + a slew of FDA updates
Sep 26, 2024•17 min
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Episode description
FDA has been busy the last week approving:
-ribociclib x 3 years in high risk stage II & III breast cancer based on the NATALEE trial as well as a new storage requirement
-osimertinib indefinitely following chemoradiation in stage III EGFR-mutated NSCLC
-amivantamab + chemotherapy following progression on osimertinib (Mariposa-2)
-a subcutaneous formulation of atezolizumab
-isatuximab + VRD for multiple myeloma
-pembrolizumab + chemotherapy for metastatic pleural mesothelioma
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