Adria's Idamycin
Executive Summary
At FDA's Sept. 10 Oncologic Drugs Advisory Committee meeting, Adria Senior Director-Medical Research Richard Gams, MD, indicated that the survival curve in the Southeastern Center Study Group (SEG) was "certainly unfavorable to patients treated with idarubicin" in the intensive maintenance arm, a distinction that was not made clear in "The Pink Sheet" (Sept. 17, p. 6). In the treatment arm, the median survival was better for idarubicin than daunorubicin. Idamycin was approved Sept. 27 in acute myeloid leukemia. Approved labeling for the drug notes that "intensive maintenance with Idamycin is not recommended".
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.