FDA Approvals, News & Updates
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 More ›
On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg; Pfizer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML. Read More ›
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 More ›