FDA Approvals, News & Updates
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 ›
A brief overview of cancer therapies approved by the FDA between June 1, 2017, and July 30, 2017. Read More ›
By Wayne Kuznar
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 More ›