New treatment for myelodysplastic syndrome approved
Celgene Corp. has been granted FDA approval for Revlimid (lenalidomide) for the treatment of patients with a subtype of myelodysplastic syndrome (MDS). The subtype is MDS patients with deletion 5q cytogenetic abnormality. In clinical trials, patients treated with lenalidomide no longer needed blood or platelet transfusions, with most patients becoming independent of transfusion by three months. The transfusion-free period lasted for an average of 44 weeks. Because lenalidomide is structurally similar to thalidomide, a drug known to cause birth defects, it is being marketed under a risk management plan called RevAssist, through which only pharmacists and prescribers registered with the program can prescribe and dispense the drug.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
