The FDA announced a trial hold after two participants with sickle cell disease (SCD) in the LentiGlobin gene therapy trials developed AML and MDS, respectively. According to bluebird bio, the manufacturer of LentiGlobin products, the company was unable to find any cancer cells in the patient’s bone marrow and has asked the FDA for permission […]
The FDA’s Oncologic Drugs Advisory Committee will hold a public meeting from April 27 to 29 to reevaluate six treatments that were previously granted accelerated approval and have since reported results that failed to verify clinical benefit. The six indications to be discussed include atezolizumab (two indications), pembrolizumab (three indications), and nivolumab (one indication).
From the pages of Oncology Times comes the latest approvals, designations, and new indications from the U.S. Food and Drug Administration (FDA) for oncology drugs. Stories include new approvals in multiple myeloma, esophageal or gastroesophageal junction (GEJ)carcinoma, non-small cell lung cancer (NSCLC), anaplastic lymphoma, and more.