Clinical Data has launched a new genetic test to predict the likelihood of a patient's response to rituximab (Rituxan, Genentech) in the treatment of follicular non-Hodgkin's lymphoma (NHL). Performed by analysis of DNA from a blood sample, the test will identify a single nucleotide polymorphism called V158F in the FCGR3A gene. According to the company, this gene encodes the Fc gamma IIIa receptor on lymphocytes to which rituximab binds. Two studies have shown that patients who carry the variant are more likely to respond to rituximab monotherapy than patients with other variants. Published data have shown that approximately 20% of patients will carry the polymorphism and be more likely to respond to treatment (an estimated 90% response rate). About half of those without the variant may still respond to treatment. More information about the test can be accessed at
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.