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CEA-Scan gets approvable letter from FDA
It's been a long road back for monoclonal antibody developer Immunomedicsand its CEA-Scan imaging agent, but the end is finally in sight.The Morris Plains, NJ, company reported this month that the Foodand Drug Administration has issued an approvable
It's been a long road back for monoclonal antibody developer Immunomedicsand its CEA-Scan imaging agent, but the end is finally in sight.The Morris Plains, NJ, company reported this month that the Foodand Drug Administration has issued an approvable letter for theagent.
CEA-Scan's path through the FDA's regulatory maze was entangledin 1994 when the agency issued a non-approvable letter for thecolorectal cancer imaging agent. Immunomedics worked with theagency to bring CEA-Scan's product license application (PLA) intoa form that FDA reviewers could accept, and an FDA panel recommendedapproval of the product in February (SCAN 2/28/96).
Final marketing approval for CEA-Scan is now subject mainlyto product labeling, Immunomedics said. Immunomedics has assignedU.S. marketing rights for the agent to Mallinckrodt Medical (SCAN4/10/96).
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
