In the News

In association with the approval of the first chimeric antigen receptor (CAR) T-cell therapy, on August 30, 2017, the FDA also accelerated the approval of a new indication as an orphan drug for toci­lizumab (Actemra; Genentech), a humanized interleukin-6 receptor antagonist, for the treatment of patients aged ≥2 years with CAR T-cell–induced severe or life-threatening cytokine release syndrome (CRS). Read Article ›

On July 31, 2017, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with mismatch repair–deficient (dMMR) and microsatellite instability–high (MSI-H) metastatic colorectal cancer (CRC) that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Read Article ›

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