ODAC Votes for Accelerated Approval of Iressa for NSCLC
n ROCKVILLE, Maryland-The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 3 that phase II results of AstraZeneca Pharmaceuticals’ EGFR tyrosine kinase inhibitor Iressa (ZD1839, gefitinib) as third-line therapy for advanced non-small-cell lung cancer (NSCLC) were "reasonably likely to predict clinical benefit." The FDA considers this a recommendation for accelerated approval. Look for a complete report of the ODAC decision and a review of the phase II trials of Iressa in NSCLC in next month’s issue of ONI.
n ROCKVILLE, MarylandThe FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 3 that phase II results of AstraZeneca Pharmaceuticals’ EGFR tyrosine kinase inhibitor Iressa (ZD1839, gefitinib) as third-line therapy for advanced non-small-cell lung cancer (NSCLC) were "reasonably likely to predict clinical benefit." The FDA considers this a recommendation for accelerated approval. Look for a complete report of the ODAC decision and a review of the phase II trials of Iressa in NSCLC in next month’s issue of ONI.
Alzheimer Disease Awareness Month 2024: Looking Back at a Year of Progress in Cell and Gene Therapy
November 24th 2024In observance of Alzheimer Disease Awareness Month, held annually in November, we took a look back at the past year's news and expert insights in cell and gene therapy for Alzheimer disease.
Evaluating Allogeneic CAR-T P-BCMA-ALLO1 in R/R Multiple Myeloma
November 21st 2024Bhagirathbhai R. Dholaria, MD, an associate professor of medicine in malignant hematology & stem cell transplantation at Vanderbilt University Medical Center, discussed interim data from the phase 1/1b clinical trial evaluating Poseida's CAR-T.
