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 Article ›

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 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 ›


A brief overview of cancer therapies approved by the FDA between June 1, 2017, and July 30, 2017. Read Article ›




Venetoclax (Venclexta) monotherapy has significant clinical activity in patients with acute myelogenous leukemia (AML) whose disease has relapsed or is resistant to chemotherapy and in those deemed unable to tolerate chemotherapy, according to a new study. Read Article ›

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