Given high complete response rates in early studies showcased at the American Society of Hematology’s recent annual meeting, acute lymphoblastic leukemia is a likely launch indication for chimeric antigen receptor immunotherapy. But while the results in B-cell malignancies are very promising so far, autologous CAR therapies are complex, and toxicities need to be carefully managed.
The first regulatory testing ground for the current generation of gene engineering technology candidates based on chimeric antigen receptors is likely to be acute lymphoblastic leukemia, an indication in which therapies can target an antigen, CD19, that is expressed only on B-cells, limiting the possibility of off-target effects.
Early studies presented at the American Society of Hematology meeting in December spurred excitement about the autologous technology’s potential in...
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
